Cleared Traditional

K770651 - RETRACTORS & HOOKS

K770651 is an FDA 510(k) clearance for RETRACTORS & HOOKS, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K770651 · Edward Weck, Inc. · General & Plastic Surgery device
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Apr 1977
Decision
8d
Days
Class 1
Risk

K770651 is an FDA 510(k) clearance for the RETRACTORS & HOOKS, ABRAMSON. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1977 after a review of 8 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K770651

510(k) Number K770651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1977
Decision Date April 14, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

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 48
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K770651.
NEIVS TRACHEOTOMY RETRACTOR
K772378 · Edward Weck, Inc. · Mar 1978
HEISS RETRACTOR
K771191 · Edward Weck, Inc. · Jul 1977
PROBE RETRACTOR, PART #S-2L8-6
K770414 · Acme United Corp. · Apr 1977
RETRACTOR, SKIN HOOK
K770418 · Acme United Corp. · Mar 1977
VANDERBILT PITUITARY RETRACTOR
K761096 · Codman & Shurtleff, Inc. · Nov 1976
SURGICAL RETRACTOR
K760422 · Cutter Laboratories, Inc. · Aug 1976