Cleared Traditional

K022843 - GAYHEART CORNEAL EXCISION DEVICE

K022843 is an FDA 510(k) clearance for GAYHEART CORNEAL EXCISION DEVICE, manufactured by Stephens Instruments. The device is a Class 1 Ophthalmic device with product code HRH cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K022843 · Stephens Instruments · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
66d
Days
Class 1
Risk

K022843 is an FDA 510(k) clearance for the GAYHEART CORNEAL EXCISION DEVICE. Classified as Trephine, Manual, Ophthalmic (product code HRH), Class I - General Controls.

Submitted by Stephens Instruments (Lexington, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022843

510(k) Number K022843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 110d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

HRH Device Classification - Class 1, General Controls

Product Code HRH Trephine, Manual, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HRH Trephine, Manual, Ophthalmic

All 11
Devices cleared under the same product code (HRH) and FDA review panel - the closest regulatory comparables to K022843.
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
K022843 · GAYHEART CORNEAL EXCISION DEVICE
Download PDF FDA Summary Stephens Instruments