510(k) Report

FDA applicant

Surgical Devices, Tyco Healthcare Group LP

North Haven, CT2 decisions2009–20091 recall

FDA records 2 decisions for Surgical Devices, Tyco Healthcare Group LP (North Haven, CT) in 2009: 2 510(k) clearances. All are in product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is 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, Tyco Healthcare Group LP’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

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

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2009high 1 (2026) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Surgical Devices, Tyco Healthcare Group LP by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 20094cite it
  • K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 20093cite it

What has FDA decided for it lately?

  • K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 20091 recall
  • K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009

All 2 as Surgical Devices, Tyco Healthcare Group LP →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091087V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Jun 24, 2026Class II