Summit Medical, Inc.
FDA Regulatory Profile
Summit Medical, Inc. appears in FDA public data with 4 recalls, 14 510(k) clearances, 12 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1171-2023, Class II) was initiated on January 13, 2023. Its most recent 510(k) clearance was granted on November 16, 2018.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 14
- Inspections
- 12
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1171-2023 | Class II | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | January 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), RH-74 | September 3, 2015 |
| Z-1731-2014 | Class II | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethyl | May 12, 2014 |
| Z-1319-2013 | Class II | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 No | March 27, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180528 | InstruSafe(R) Sterilization Container | November 16, 2018 |
| K173110 | GRAFTSITE | May 18, 2018 |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | July 25, 2017 |
| K162046 | MINNE TIES MMF Suture System | April 11, 2017 |
| K151166 | Instru-Safe Instrument Protection System | August 18, 2015 |
| K150540 | Instru-Safe Instrument Protection System | June 22, 2015 |
| K142768 | Instru-Safe Instrument Protection System | May 29, 2015 |
| K142630 | Instru-Safe Instrument Protection System | December 23, 2014 |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | December 15, 2014 |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | June 27, 2014 |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | March 13, 2014 |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | February 14, 2003 |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMI | October 25, 2002 |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | October 9, 2002 |