510(k) Report

FDA applicant

Tnco, Inc.

Whitman, MA4 decisions1994–19941 recall

FDA records 4 decisions for Tnco, Inc. (Whitman, MA) in 1994: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Tnco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tnco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tnco, Inc. 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • HRXArthroscope1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

What has FDA decided for it lately?

  • K943958Monopolar Endoscopic Reposable Tip Surgical InstrumentsTnco, Inc. · 19941 recall
  • K940554Tnco, Inc. Arthroscopic Surgical InstrumentsTnco, Inc. · 1994
  • K940552Monopolar Surgical InstrumentsTnco, Inc. · 1994
  • K940551Endoscopic Surgical InstrumentsTnco, Inc. · 1994

All 4 as Tnco, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K943958Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A)…Dec 2, 2005