Data / Medical devices / France / Peters Surgical
Peters Surgical: FDA-registered device maker in BOULOGNE-BILLANCOURT Hauts-de-Seine, France, 8 510(k) clearances
Peters Surgical is registered with the FDA (registration 3004060107) in BOULOGNE-BILLANCOURT Hauts-de-Seine, France. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 11, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004060107
- Address
- Immeuble Aurelium 1 cours de l'ile Seguin, BOULOGNE-BILLANCOURT Hauts-de-Seine, France, 92100
- Owner or operator
- PETERS SURGICAL (9009304)
- Roles
- Exporter to the US, Specification developer
- First device listed
- June 21, 1994
- Registered through
- 2026
- Brand names listed
- ACIER SUTURES, ADVANTIME, Applier for VITALITEC Hemostatic Clips, CARDIOFLON EVOLUTION, CARDIONYL, CARDIOXYL, CLIP 9 VITALITEC® TITANIUM HEMOSTATIC CLIP, COROLENE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Hemostatic Clip | HBT | 1 | Exporter to the US | accessdata.fda.gov |
| Clip, Implantable | FZP | 2 | Exporter to the US | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Exporter to the US | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2024 | K233265 | Monotime and Optime R | GAM | Substantially Equivalent | Peters Surgical | accessdata.fda.gov |
| July 12, 2024 | K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | GAM | Substantially Equivalent | Peters Surgical | accessdata.fda.gov |
| October 11, 2006 | K060163 | CARDIOFLON, CARDIOXYL | GAT | Substantially Equivalent | Peters Surgical | accessdata.fda.gov |
| October 2, 2006 | K062366 | OPTIME, SINUSORB PGA | GAM | Substantially Equivalent | Peters Surgical | accessdata.fda.gov |
| December 13, 2005 | K052701 | COROLENE | GAW | Substantially Equivalent | Peters Surgical | accessdata.fda.gov |
| July 30, 1999 | K991073 | ACIER SUTURES | GAQ | Substantially Equivalent | Cardio Thoracic Systems | accessdata.fda.gov |
| October 13, 1998 | K981645 | TITANIUM HEMOSTATIC CLIP | FZP | Substantially Equivalent | Vitalitec Int'L., Inc. | accessdata.fda.gov |
| August 3, 1992 | K913102 | PETERS CARDIONYL(TM) SUTURE | GAR | Substantially Equivalent | Promedica Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2014 | 68721 | Class II | Terminated | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOX | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. | accessdata.fda.gov |
Compare with other makers
- All makers of Applier, Hemostatic Clip
- All makers of Clip, Implantable
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Laparoscopic Accessories, Gynecologic
Updated October 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.