510(k) Report

FDA applicant

Surgical Specialties Corp

Reading, PA33 decisions1986–20161 recall

FDA records 33 decisions for Surgical Specialties Corp (Reading, PA) from 1986 to 2016: 33 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). Its devices cite 38 predicates, 17 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Surgical Specialties, Inc.”, “Surgical Specialties Corporation”.

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 Surgical Specialties Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 32008: 22014: 42016: 1
2007high 4 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgical Specialties Corp 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 Acid8decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene5decisions
  • NEWSuture, Surgical, Absorbable, Polydioxanone5decisions
  • EFQGauze/Sponge, Internal4decisions
  • GAPSuture, Nonabsorbable, Silk2decisions
  • HNOKeratome, Ac-Powered1decision

Also: NBY (1), GAR (1), MTJ (1), GAT (1), KXK (1), GAN (1).

Whose devices does it build on?

Its devices cite 38 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 47 times; 17 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.

  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 20087cite it
  • K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 20075cite it
  • K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 20045cite it
  • K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 20053cite it
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 20083cite it
  • K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 20053cite it

What has FDA decided for it lately?

  • K160744LOOK PTFE SutureSurgical Specialties Corporation · 2016
  • K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
  • K141625Polysyn Surgical SutureSurgical Specialties Corp · 2014
  • K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp · 2014
  • K140227Monoderm Surgical SutureSurgical Specialties Corp · 2014
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007

All 22 as Surgical Specialties Corp →All 9 as Surgical Specialties, Inc. →All 2 as Surgical Specialties Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K9308253-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended…Sep 9, 2008