Cleared Traditional

GAYHEART CORNEAL EXCISION DEVICE

K022843 · Stephens Instruments · Ophthalmic
Nov 2002
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K022843 is an FDA 510(k) clearance for the GAYHEART CORNEAL EXCISION DEVICE, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Stephens Instruments (Lexington, US). The FDA issued a Cleared decision on November 1, 2002, 66 days after receiving the submission on August 27, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K022843 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2002
Decision Date November 01, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HRH — Trephine, Manual, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

Similar Devices — HRH Trephine, Manual, Ophthalmic

All 11
ARTHROSCOPE
K931792 · Intramed Laboratories, Inc. · Jun 1994
HEAD & CHIN RESTS
K873918 · Richmond Products, Inc. · Oct 1987
BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON
K864520 · Precision Instruments, Inc. · Jan 1987
DEKNATEL (R) TREPHINE
K862524 · Deknatel, Inc. · Aug 1986
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K861825 · Storz Instrument Co. · Jun 1986
BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
K860648 · Precision Instruments, Inc. · Mar 1986