Surgical Innovations Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1601-2023 | Class II | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | March 28, 2023 |
| Z-1602-2023 | Class II | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | March 28, 2023 |
| Z-1396-2022 | Class II | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | June 2, 2022 |
| Z-1852-2022 | Class II | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adap | January 20, 2022 |
| Z-1853-2022 | Class II | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures. | January 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123110 | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 | January 17, 2013 |
| K112659 | SURGICAL RETRACTORS | March 9, 2012 |
| K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | January 26, 2012 |
| K100109 | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE | July 15, 2010 |
| K063485 | LOGIC LAPAROSCOPIC SCISSORS | December 1, 2006 |
| K955393 | NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | January 9, 1997 |
| K962193 | PORTLAND TROCARS | August 28, 1996 |
| K944292 | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SUR | November 15, 1994 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | March 28, 1994 |
| K914098 | LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR | October 28, 1991 |