510(k) Report

FDA applicant

Surgical Specialties Corp. Dba Angiotech

Reading, PA8 decisions2012–20131 recall

FDA records 8 decisions for Surgical Specialties Corp. Dba Angiotech (Reading, PA) from 2012 to 2013: 8 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Its devices cite 24 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Surgical Specialties Corporation Dba Angiotech”.

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. Dba Angiotech’s devices, and how often a recall has named them.

FDA decisions per year

5in 2013

2012: 32013: 5
2012high 5 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2012high 1 (2022) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Surgical Specialties Corp. Dba Angiotech by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Specialties Corp. Dba Angiotech’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions
  • NEWSuture, Surgical, Absorbable, Polydioxanone3decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene2decisions

Whose devices does it build on?

Its devices cite 24 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 6 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.

  • K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20124cite it
  • K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20133cite it
  • K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20123cite it
  • K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20132cite it
  • K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech · 20132cite it
  • K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20122cite it

What has FDA decided for it lately?

  • K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech · 2013
  • K132268Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation Dba Angiotech · 2013
  • K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless…Surgical Specialties Corp. Dba Angiotech · 2013
  • K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2013
  • K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2013
  • K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
  • K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
  • K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 20121 recall

All 7 as Surgical Specialties Corp. Dba Angiotech →The one decision as Surgical Specialties Corporation Dba Angiotech →

What has been recalled?

1 recall linked to its devices; the latest:

  • K122898STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code…Mar 24, 2022Class II