Cleared Abbreviated

CLEARCUT S SAFETY KNIFE

K110166 · Alcon Research, Ltd. · Ophthalmic
May 2011
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K110166 is an FDA 510(k) clearance for the CLEARCUT S SAFETY KNIFE, a Knife, Ophthalmic (Class I — General Controls, product code HNN), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on May 20, 2011, 120 days after receiving the submission on January 20, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K110166 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2011
Decision Date May 20, 2011
Days to Decision 120 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNN — Knife, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

Similar Devices — HNN Knife, Ophthalmic

All 53
OPHTHALMIC KNIFE
K922378 · Microptics Development Laboratory · Dec 1992
RETRACTIVE INCISION MICROMETER (RIM) GUAGE
K882402 · Optical Center · Aug 1988
MVR/STILETTO BLADE 20GA. - P/N 1900
K881669 · Advanced Surgical Products, Inc. · May 1988
PRISMA DISPOSABLE MVR/STILETTO BLADE
K874979 · Advanced Surgical Products, Inc. · Apr 1988
OPHTHALMIC TIP & BLADE SCALPELS
K874057 · Myocure, Inc. · Dec 1987
OPHTHALMIC DISPOSABLE BLADES
K874056 · Myocure, Inc. · Dec 1987