Cleared Traditional

BINKHORST LENS FORCEPS W/OUT IRRIGATOR (K770104) - FDA 510(k) Clearance

Class I Ophthalmic device.

K770104 · Edward Weck, Inc. · Ophthalmic device
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Jan 1977
Decision
7d
Days
Class 1
Risk

K770104 is an FDA 510(k) clearance for the BINKHORST LENS FORCEPS W/OUT IRRIGATOR. 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 January 24, 1977 after a review of 7 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

Submission Details

510(k) Number K770104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1977
Decision Date January 24, 1977
Days to Decision 7 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
103d faster than avg
Panel avg: 110d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 13
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K770104.
SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK
K770099 · Edward Weck, Inc. · Jan 1977
BINKHORST LENS FORCEP W/ IRRIGATOR
K770100 · Edward Weck, Inc. · Jan 1977
HERSHMAN LENS FORCEPS W/OUT IRRIGATOR
K770102 · Edward Weck, Inc. · Jan 1977
WECK TYING FORCEP, STRAIGHT TITANIUM
K761251 · Edward Weck, Inc. · Dec 1976
WECK TYING FORCEP, CURVED TITANIUM
K761252 · Edward Weck, Inc. · Dec 1976