510(k) Report

FDA applicant

American Silk Sutures, Inc.

Lynn, MA14 decisions1985–199265 recalls

FDA records 14 decisions for American Silk Sutures, Inc. (Lynn, MA) from 1985 to 1992: 14 510(k) clearances. Most are in product codes HBA (Neurosurgical Paddie) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 65 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 American Silk Sutures, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Silk Sutures, Inc. since 2007.

Recalls per year

1in 2024

2016: 642024: 1
2007high 64 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Silk Sutures, Inc. 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?

  • HBANeurosurgical Paddie4decisions
  • GDYGauze/Sponge, Internal, X-Ray Detectable3decisions
  • EFQGauze/Sponge, Internal2decisions
  • EPPSplint, Nasal1decision
  • GEACannula, Surgical, General & Plastic Surgery1decision
  • EFNCotton, Roll1decision

Also: GET (1), KME (1).

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K862494Polyester Sponge PattieAmerican Silk Sutures, Inc. · 19861cites it
  • K902921Rayon Neurological SpongeAmerican Silk Sutures, Inc. · 19901cites it

What has FDA decided for it lately?

  • K922143American Burn SheetAmerican Silk Sutures, Inc. · 1992
  • K904514Strung Telfa Non-Adherent SpongeAmerican Silk Sutures, Inc. · 19917 recalls
  • K902921Rayon Neurological SpongeAmerican Silk Sutures, Inc. · 199012 recalls
  • K872810Strung Dental RollsAmerican Silk Sutures, Inc. · 19871 recall
  • K872951American Brain Retractor CoverAmerican Silk Sutures, Inc. · 1987
  • K872905American Nasal SpongeAmerican Silk Sutures, Inc. · 1987
  • K872906Suction Tube Tip Fits Over Bussie Frazier TubeAmerican Silk Sutures, Inc. · 1987
  • K872807Non-Woven Tracheotomy SpongeAmerican Silk Sutures, Inc. · 1987

All 14 as American Silk Sutures, Inc. →

What has been recalled?

65 recalls linked to its devices; the latest:

  • K854714Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the…Sep 18, 2024Class II
  • K854714American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage…Mar 31, 2016Class II
  • K862494American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and…Mar 31, 2016Class II
  • K854714American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage…Mar 31, 2016Class II
  • K854714American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage…Mar 31, 2016Class II
  • K902921American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and…Mar 31, 2016Class II