Cleared Traditional

ULTRACELL ABSORBENT STICK

K012196 · Ultracell Medical Technologies, Inc. · Ophthalmic
Aug 2001
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K012196 is an FDA 510(k) clearance for the ULTRACELL ABSORBENT STICK, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on August 24, 2001, 42 days after receiving the submission on July 13, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K012196 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2001
Decision Date August 24, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

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