Cleared Traditional

THOREK SCISSORS 7 1/4 & 10 (K771806) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K771806 · J. Sklar Mfg. Co., Inc. · General & Plastic Surgery device
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Oct 1977
Decision
11d
Days
Class 1
Risk

K771806 is an FDA 510(k) clearance for the THOREK SCISSORS 7 1/4 & 10. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 K771806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1977
Decision Date October 04, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZT Cutter, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.