Cleared Traditional

K770418 - RETRACTOR

K770418 is the FDA 510(k) clearance for RETRACTOR by Acme United Corp.. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K770418 · Acme United Corp. · General & Plastic Surgery device
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Mar 1977
Decision
19d
Days
Class 1
Risk

K770418 is an FDA 510(k) clearance for the RETRACTOR, SKIN HOOK. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1977 after a review of 19 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 Acme United Corp. devices

Submission Details

510(k) Number K770418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1977
Decision Date March 23, 1977
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
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.

Regulatory Peers - GAD Retractor

All 39
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K770418.
NEIVS TRACHEOTOMY RETRACTOR
K772378 · Edward Weck, Inc. · Mar 1978
HEISS RETRACTOR
K771191 · Edward Weck, Inc. · Jul 1977
RETRACTORS & HOOKS, ABRAMSON
K770651 · Edward Weck, Inc. · Apr 1977
VANDERBILT PITUITARY RETRACTOR
K761096 · Codman & Shurtleff, Inc. · Nov 1976
SURGICAL RETRACTOR
K760422 · Cutter Laboratories, Inc. · Aug 1976