Surgical Innovations Ltd
FDA Regulatory Profile
Surgical Innovations Ltd has 5 FDA recalls, 4 inspections, 12 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1602-2023 · Class II · Mar 28, 2023
- Latest inspection
- Oct 24, 2023 · NAI
- Latest 510(k)
- Jun 18, 2021
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 4 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1602-2023 | Class II | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | Mar 28, 2023 |
| Z-1601-2023 | Class II | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Mar 28, 2023 |
| Z-1396-2022 | Class II | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | Jun 2, 2022 |
| Z-1852-2022 | Class II | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson… | Jan 20, 2022 |
| Z-1853-2022 | Class II | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures. | Jan 20, 2022 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 24, 2023 | San Juan, PR | Biologics | No Action Indicated (NAI) | 3009541737 |
| Apr 11, 2019 | San Juan, PR | Biologics | No Action Indicated (NAI) | 3009541737 |
| Jul 27, 2016 | San Juan, PR | Biologics | Voluntary Action Indicated (VAI) | 3009541737 |
| Apr 21, 2014 | Theodore, AL | Biologics | No Action Indicated (NAI) | 3008702798 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210495 | Port Access System | Jun 18, 2021 |
| K190592 | YelloPort Elite Port Access System | Apr 29, 2019 |
| K123110 | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 | Jan 17, 2013 |
| K112659 | SURGICAL RETRACTORS | Mar 9, 2012 |
| K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | Jan 26, 2012 |
| K100109 | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE | Jul 15, 2010 |
| K063485 | LOGIC LAPAROSCOPIC SCISSORS | Dec 1, 2006 |
| K955393 | NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | Jan 9, 1997 |
| K962193 | PORTLAND TROCARS | Aug 28, 1996 |
| K944292 | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE… | Nov 15, 1994 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Mar 28, 1994 |
| K914098 | LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR | Oct 28, 1991 |