Cleared Traditional

K770163 - SUTURE CUTTER (FDA 510(k) Clearance)

Class I General Hospital device.

K770163 · Concept, Inc. · General Hospital
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Mar 1977
Decision
64d
Days
Class 1
Risk

K770163 is an FDA 510(k) clearance for the SUTURE CUTTER. Classified as Scissors, Medical, Disposable (product code JOK), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1977 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6820 - the FDA general hospital 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 Concept, Inc. devices

Submission Details

510(k) Number K770163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1977
Decision Date March 30, 1977
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 128d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JOK Scissors, Medical, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6820
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.