510(k) Report

FDA applicant

Surgical Devices, A Division of Tyco Healthcare

North Haven, CT3 decisions2009–20102 recalls

FDA records 3 decisions for Surgical Devices, A Division of Tyco Healthcare (North Haven, CT) from 2009 to 2010: 3 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and FZP (Clip, Implantable). Its devices cite 9 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 Surgical Devices, A Division of Tyco Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 12010: 2
2009high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2009high 2 (2026) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Surgical Devices, A Division of Tyco Healthcare by year, 2009–2026Sources: 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 Acid2decisions
  • FZPClip, Implantable1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 20102cite it

What has FDA decided for it lately?

  • K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 20101 recall
  • K100242Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare · 2010
  • K093408V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 20091 recall

All 3 as Surgical Devices, A Division of Tyco Healthcare →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K100257V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22…Jun 24, 2026Class II
  • K091087V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Jun 24, 2026Class II