510(k) Report

FDA applicant

United States Surgical, A Division of Tyco Healthc

Norwalk, CT218 decisions1977–200786 recalls

FDA records 218 decisions for United States Surgical, A Division of Tyco Healthc (Norwalk, CT) from 1977 to 2007: 218 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GDW (Staple, Implantable). Its devices cite 62 predicates, 31 of them its own earlier devices. 86 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 United States Surgical, A Division of Tyco Healthc’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2026

2010: 22011: 112012: 52016: 72017: 52018: 12019: 302020: 42021: 12022: 82023: 12024: 12026 (partial year): 2
2007high 30 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — United States Surgical, A Division of Tyco Healthc by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like United States Surgical, A Division of…’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?

  • GCJLaparoscope, General & Plastic Surgery30decisions
  • GDWStaple, Implantable28decisions
  • FZPClip, Implantable17decisions
  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid12decisions
  • HETLaparoscope, Gynecologic (And Accessories)9decisions
  • HAOInstrument, Surgical, Non-Powered7decisions

Also: GAP (5), GEI (5), FTL (5), HRX (5), GAL (4), KWQ (4).

Whose devices does it build on?

Its devices cite 62 predicates; 31 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 259 times; 31 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.

  • K003709Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc · 200114cite it
  • K971680Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 19978cite it
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 20068cite it
  • K061095Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 20067cite it
  • K903419Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc · 19906cite it
  • K922123Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 19936cite it

What has FDA decided for it lately?

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006
  • K061095Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K050947Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 20052 recalls
  • K042412Modified Spacemaker SystemUnited States Surgical, A Division of Tyco Healthc · 2004

All 218 as United States Surgical, A Division of Tyco Healthc →

What has been recalled?

86 recalls linked to its devices; the latest:

  • K050947Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXJun 24, 2026Class II
  • K934738Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;Apr 15, 2026Class II
  • K981128Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile…Jan 25, 2024Class II
  • K981128Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0…Dec 21, 2023Class II
  • K955747Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI…Dec 2, 2022Class II
  • K900531Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson…Dec 2, 2022Class II