Cleared Traditional

K022835 - STEPHENS DISPOSABLE FORCEPS

K022835 is an FDA 510(k) clearance for STEPHENS DISPOSABLE FORCEPS, manufactured by Stephens Instruments. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K022835 · Stephens Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
66d
Days
Class 1
Risk

K022835 is an FDA 510(k) clearance for the STEPHENS DISPOSABLE FORCEPS. Classified as Forceps, Ophthalmic (product code HNR), 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.

View all Stephens Instruments devices

FDA 510(k) Submission Details - K022835

510(k) Number K022835 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
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 110d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

HNR Device Classification - Class 1, General Controls

Product Code HNR Forceps, 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 - HNR Forceps, Ophthalmic

All 33
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K022835.
ALCON FOLDING FORCEPS
K895434 · Alcon Laboratories · Dec 1989
MCDONALD FOLDING FORCEPS
K885230 · Alcon Laboratories · May 1989
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
K880274 · Advanced Surgical Products, Inc. · Feb 1988
FAULKNER FORCEPS
K864071 · Staar Surgical Co. · Nov 1986
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
K863991 · Keeler Instruments, Inc. · Oct 1986
THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
K863992 · Keeler Instruments, Inc. · Oct 1986