Ultracell Ear Wick

FDA 510(k) K920357 · Ultracell Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK920357

Submission

Device name
Ultracell Ear Wick
Applicant
Ultracell Medical Technologies, Inc.
North Stonington, CT, US
Received
January 27, 1992
Decision date
February 1, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KCN – Ear Wick
Device class
Class I (low risk)
Regulation
21 CFR 874.5220
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KCN

510(k)DeviceApplicantDecision
K062540Nasopore Ear, Models ND04, ND05KCN · Traditional Polyganics B.V.,10/18/2006SE
K973578Invotec Ear Tampon (Wick) W/StringKCN · Traditional Invotec International, Inc.11/06/1997SE
K791059Pope Oto-Wick, Sterile & Non-SterileKCN · Traditional Xomed, Inc.07/17/1979SE

More from Xomed, Inc.

510(k)DeviceDecision
K012196Ultracell Absorbent StickHOZ · Traditional 08/24/2001SE
K972634Ultracell Suction SpongeGDY · Traditional 12/17/1997SE
K972633Ultracell Suction SpongeHOZ · Traditional 12/17/1997SE
K973083Ultracell Neuro SpongesHBA · Traditional 12/09/1997SE
K973558Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional 11/24/1997SE
K973085Ultracell Packing with SleeveEMX · Traditional 11/18/1997SE
K972635Ultracell Suction SpongeGBX · Traditional 10/01/1997SE
K970328Ultracell Neuro SpongesHBA · Traditional 04/21/1997SE
K950647Ultracell Neuro SpongesHBA · Traditional 08/15/1995SE
K950373Ultracell Orthopedic SpongesGDY · Traditional 04/17/1995SE

Questions and answers

When was Ultracell Ear Wick cleared by the FDA?

Ultracell Ear Wick (K920357) received a 510(k) decision of Substantially Equivalent on February 1, 1993, 371 days after the submission was received.

What is the product code of K920357?

The FDA product code is KCN – Ear Wick, a Class I (low risk) device regulated under 21 CFR 874.5220.