510(k) Report

FDA applicant

Peters Surgical

Bobigny, FR7 decisions2005–20242 recalls

FDA records 7 decisions for Peters Surgical (Bobigny, FR) from 2005 to 2024: 7 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). Its devices cite 10 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Peters Surgical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007: 22024: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2014

2014: 2
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Peters Surgical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision
  • MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)1decision
  • KRHRing, Annuloplasty1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062366Optime, Sinusorb PgaPeters Surgical · 20061cites it

What has FDA decided for it lately?

  • K233265Monotime and Optime RPeters Surgical · 2024
  • K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024
  • K071281Uniring - Annuloplasty Ring with SizersPeters Surgical · 2007
  • K060465PremioPeters Surgical · 2007
  • K060163Cardioflon, CardioxylPeters Surgical · 20062 recalls
  • K062366Optime, Sinusorb PgaPeters Surgical · 2006
  • K052701CorolenePeters Surgical · 2005

All 7 as Peters Surgical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K060163The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of…Jun 25, 2014Class II
  • K060163The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester…Jun 25, 2014Class II