510(k) Report

FDA applicant

Taut, Inc.

Geneva, IL16 decisions1983–20027 recalls

FDA records 16 decisions for Taut, Inc. (Geneva, IL) from 1983 to 2002: 16 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GBW (Catheter, Peritoneal). 7 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 Taut, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taut, Inc. since 2007.

Recalls per year

1in 2015

2007: 12014: 52015: 1
2007high 5 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Taut, 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 Surgery5decisions
  • GBWCatheter, Peritoneal3decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • KKXDrape, Surgical, Antimicrobial2decisions
  • GBXCatheter, Irrigation1decision
  • GBZCatheter, Cholangiography1decision

Also: HIF (1), GCA (1).

Who builds on its devices?

Later devices cite its devices 14 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.

  • K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 20018cite it
  • K992904Mini-PortTaut, Inc. · 19992cite it
  • K003703Taut-Insufflation NeedleTaut, Inc. · 20012cite it
  • K011018Taut Balloon Catheter, Model 50640Taut, Inc. · 20011cites it
  • K023261Adapt Balloon Open Access Port, Model 41244Taut, Inc. · 20021cites it

What has FDA decided for it lately?

  • K023261Adapt Balloon Open Access Port, Model 41244Taut, Inc. · 2002
  • K021731Adapt Open Access Port, Model 41233Taut, Inc. · 20022 recalls
  • K011018Taut Balloon Catheter, Model 50640Taut, Inc. · 2001
  • K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 20013 recalls
  • K003703Taut-Insufflation NeedleTaut, Inc. · 2001
  • K992904Mini-PortTaut, Inc. · 1999
  • K992907IntraducerTaut, Inc. · 19991 recall
  • K972112Intraducer Port SC Catalog#31275,31035,30915, and 31450Taut, Inc. · 1997

All 16 as Taut, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K992907Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the…Oct 14, 2015Class II
  • K0217315/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An…Mar 11, 2014Class II
  • K0100075/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista…Mar 11, 2014Class II
  • K0100075/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope…Mar 11, 2014Class II
  • K0217315/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope…Mar 11, 2014Class II
  • K0100075/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories…Mar 11, 2014Class II