Summit Medical, Inc. FDA Record
- Latest inspection VAI · May 14, 2018
- Last warning letter 2013
Summit Medical, Inc. has 4 FDA recalls, 12 inspections, 14 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Summit Medical, Inc., the most recent on Apr 25, 2013.
- Latest recall
- Z-1171-2023 · Class II · Jan 13, 2023
- Latest inspection
- May 14, 2018 · VAI
- Latest 510(k)
- Nov 16, 2018
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 14 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 12 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Summit Medical, Inc.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Summit Medical, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Apr 25, 2013 · Record page |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1171-2023 | Class II | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | Jan 13, 2023 |
| Z-0435-2016 | Class II | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H)… | Sep 3, 2015 |
| Z-1731-2014 | Class II | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by… | May 12, 2014 |
| Z-1319-2013 | Class II | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815… | Mar 27, 2013 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 14, 2018 | Eagan, MN | Devices | Voluntary Action Indicated (VAI) | 3008719017 |
| Mar 9, 2018 | Eagan, MN | Devices | Voluntary Action Indicated (VAI) | 3008719017 |
| Nov 10, 2016 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
| Aug 5, 2015 | Gloucestershire, United Kingdom | Devices | No Action Indicated (NAI) | 1000345108 |
| Mar 4, 2015 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
| May 5, 2014 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
| May 2, 2013 | Baton Rouge, LA | Biologics | No Action Indicated (NAI) | 3006847468 |
| Jan 28, 2013 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
| Sep 7, 2012 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
| Jun 7, 2011 | Baton Rouge, LA | Biologics | No Action Indicated (NAI) | 3006847468 |
| Dec 2, 2010 | Gloucestershire, United Kingdom | Devices | No Action Indicated (NAI) | 1000345108 |
| Nov 6, 2009 | Eagan, MN | Devices | No Action Indicated (NAI) | 3008719017 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Summit Medical, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008719017 | Eagan, MN | 8 | May 14, 2018 |
| FEI 1000345108 | Gloucestershire, United Kingdom | 2 | Aug 5, 2015 |
| FEI 3006847468 | Baton Rouge, LA | 2 | May 2, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K180528 | InstruSafe(R) Sterilization Container | Nov 16, 2018 |
| K173110 | GRAFTSITE | May 18, 2018 |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Jul 25, 2017 |
| K162046 | MINNE TIES MMF Suture System | Apr 11, 2017 |
| K151166 | Instru-Safe Instrument Protection System | Aug 18, 2015 |
| K150540 | Instru-Safe Instrument Protection System | Jun 22, 2015 |
| K142768 | Instru-Safe Instrument Protection System | May 29, 2015 |
| K142630 | Instru-Safe Instrument Protection System | Dec 23, 2014 |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Dec 15, 2014 |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Jun 27, 2014 |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Mar 13, 2014 |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | Feb 14, 2003 |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH… | Oct 25, 2002 |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | Oct 9, 2002 |
Summit Medical, Inc. and the FDA: common questions
Has Summit Medical, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Summit Medical, Inc.. The most recent is dated Apr 25, 2013.
Has Summit Medical, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Summit Medical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Summit Medical, Inc.?
The most recent FDA inspection on file ended May 14, 2018 at Eagan, MN and was classified VAI. FDA has 12 inspections of Summit Medical, Inc. on file.
Has Summit Medical, Inc. had an FDA recall?
Yes. Summit Medical, Inc. has 4 FDA recalls on record. The most recent started Jan 13, 2023.
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