510(k) Report

FDA applicant

Ultracell Medical Technologies, Inc.

North Stonington, CT24 decisions1992–200113 recalls

FDA records 24 decisions for Ultracell Medical Technologies, Inc. (North Stonington, CT) from 1992 to 2001: 24 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and EMX (Balloon, Epistaxis). 13 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 Ultracell Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ultracell Medical Technologies, Inc. since 2007.

Recalls per year

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ultracell Medical Technologies, 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?

  • GDYGauze/Sponge, Internal, X-Ray Detectable7decisions
  • EMXBalloon, Epistaxis5decisions
  • HOZSponge, Ophthalmic4decisions
  • HBANeurosurgical Paddie3decisions
  • KCNEar Wick1decision
  • HEPMonitor, Blood-Flow, Ultrasonic1decision

Also: LYA (1), GBX (1), FEB (1).

Who builds on its devices?

Later devices cite its devices 5 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.

  • K923922Surgical SpearsUltracell Medical Technologies, Inc. · 19932cite it
  • K920355Specialty SpongesUltracell Medical Technologies, Inc. · 19921cites it
  • K920358Ultracell Nasal PackingUltracell Medical Technologies, Inc. · 19921cites it
  • K920354Ophthalmic SpongesUltracell Medical Technologies, Inc. · 19921cites it

What has FDA decided for it lately?

  • K012196Ultracell Absorbent StickUltracell Medical Technologies, Inc. · 2001
  • K972634Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K972633Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K973083Ultracell Neuro SpongesUltracell Medical Technologies, Inc. · 1997
  • K973558Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)Ultracell Medical Technologies, Inc. · 1997
  • K973085Ultracell Packing with SleeveUltracell Medical Technologies, Inc. · 1997
  • K972635Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K970328Ultracell Neuro SpongesUltracell Medical Technologies, Inc. · 1997

All 24 as Ultracell Medical Technologies, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K920354Ultracell Wick with 80cc Collection Bag, 20/boxDec 20, 2022Class II
  • K920357BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM (10/BX) BVRVIS…May 25, 2022Class II
  • K920358Ultracell 8.0 cm Nasal Packing w/tube Catalog #:10110-CTJan 8, 2003
  • K920357Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-CJan 8, 2003
  • K920357Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric) Catalog #: 30301-CJan 8, 2003
  • K923922PVA Foam Surgical Spears Catalog #: OASIS0525Jan 8, 2003