Cleared Traditional

K770040 - SCISSORS

K770040 is the FDA 510(k) clearance for SCISSORS by J. Sklar Mfg. Co., Inc.. It is a Class 1 Ophthalmic device (product code HNF) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770040 · J. Sklar Mfg. Co., Inc. · Ophthalmic device
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Jan 1977
Decision
4d
Days
Class 1
Risk

K770040 is an FDA 510(k) clearance for the SCISSORS, STRABIMUS, 4 STRAIGHT. Classified as Scissors, Ophthalmic (product code HNF), Class I - General Controls.

Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1977 after a review of 4 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 J. Sklar Mfg. Co., Inc. devices

Submission Details

510(k) Number K770040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1977
Decision Date January 14, 1977
Days to Decision 4 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 110d · This submission: 4d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNF Scissors, 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 - HNF Scissors, Ophthalmic

All 9
Devices cleared under the same product code (HNF) and FDA review panel - the closest regulatory comparables to K770040.
IRIS SCISSORS STRAIGHT 4 1/2
K821286 · Conphar, Inc. · May 1982
LITTAUER SCISSORS 5 1/2
K821290 · Conphar, Inc. · May 1982
OPHTHALMIC SCISSORS
K811245 · Keeler Instruments, Inc. · Jul 1981
SCISSORS, MICRO IRIS STRAIGHT
K760185 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976
SCISSORS, MICRO IRIS CURVED
K760188 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976
SCISSORS, IRIS STRAIGHT
K760190 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976