ULTRACELL EAR WICK— 510(k) K920357

Name: FDA 510(k) clearance K920357
Creator: U.S. Food and Drug Administration
Published: 1993-02-01

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K920357 for ULTRACELL EAR WICK, Substantially Equivalent on 1993-02-01. Applicant: Ultracell Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code KCN
Device class: Class 1
Regulation: 21 CFR 874.5220
Advisory panel: Ear, Nose, Throat
Date received: 1992-01-27
Decision date: 1993-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCN

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K062540 — NASOPORE EAR, MODELS ND04, ND052006-10-18
K973578 — INVOTEC EAR TAMPON (WICK) W/STRING1997-11-06
K791059 — POPE OTO-WICK, STERILE & NON-STERILE1979-07-17

More clearances from Ultracell Medical Technologies, Inc.

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K012196 — ULTRACELL ABSORBENT STICK2001-08-24
K972633 — ULTRACELL SUCTION SPONGE1997-12-17
K972634 — ULTRACELL SUCTION SPONGE1997-12-17
K973083 — ULTRACELL NEURO SPONGES1997-12-09
K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)1997-11-24

Recalls naming K920357

K-number listed on FDA's recall record

Z-1625-2022 — BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-CClass II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920357.

Data sourced from openFDA. This site is unofficial and independent of the FDA.