Atlas FDA

ULTRACELL EAR WICK

FDA 510(k) clearance K920357 · decided 1993-02-01

Clearance details

K-number
K920357
Device name
ULTRACELL EAR WICK
Applicant
Ultracell Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
1992-01-27
Decision date
1993-02-01
Days to decision
371 days
Clearance type
Traditional
Product code
KCN
Device class
1
Regulation number
874.5220
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
North Stonington, CT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NASOPORE EAR, MODELS ND04, ND05 (K062540)Polyganics B.V.,2006-10-18
INVOTEC EAR TAMPON (WICK) W/STRING (K973578)Invotec International, Inc.1997-11-06
POPE OTO-WICK, STERILE & NON-STERILE (K791059)Xomed, Inc.1979-07-17

Recalls involving this device

RecordFirmDate
BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catal recall (Z-1625-2022)Mckesson Medical-Surgical Inc. Corporate Office2022-08-26
Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-C recall (Z-0480-03)Ultracell Medical Technologies2003-01-30
Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric) Catalog #: 30301-C recall (Z-0481-03)Ultracell Medical Technologies2003-01-30
Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C recall (Z-0482-03)Ultracell Medical Technologies2003-01-30
Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C recall (Z-0483-03)Ultracell Medical Technologies2003-01-30
Otocell Ear Wick 15mm Catalog #: BMPEW0915 recall (Z-0485-03)Ultracell Medical Technologies2003-01-30