Cleared Traditional

K801465 - GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE

K801465 is an FDA 510(k) clearance for GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE, manufactured by Edward Weck, Inc.. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801465 · Edward Weck, Inc. · Ophthalmic device
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Jul 1980
Decision
34d
Days
Class 1
Risk

K801465 is an FDA 510(k) clearance for the GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 34 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K801465

510(k) Number K801465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 28, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
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 29
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K801465.
MICROSURGICAL INSTRUMENTS
K823174 · Concept, Inc. · Nov 1982
ANIS LENS IMPLANT FORCEPS #2
K811658 · American V. Mueller · Jun 1981
FISHER-PICKERING INTRAOCULAR EYE MAGNET
K803194 · Storz Instrument Co. · Feb 1981
DODICK LENS HOLDING FORCEPS
K801467 · Edward Weck, Inc. · Jul 1980
OPHTHALMIC FORCEPS
K800368 · Edward Weck, Inc. · Mar 1980
FIX. & LENS FOR. #'S 3510,3512,3248,3795
K791986 · Edward Weck, Inc. · Oct 1979