Cleared Traditional

DEEP BALFOUR BLADE FOR WILKINSON RETRACT (K801611) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K801611 · Edward Weck, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
20d
Days
Class 1
Risk

K801611 is an FDA 510(k) clearance for the DEEP BALFOUR BLADE FOR WILKINSON RETRACT. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 20 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

Submission Details

510(k) Number K801611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 04, 1980
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 13
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K801611.
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980
ULTRASOUND IMAGING SYSTEM
K780993 · Boehringer Mannheim Corp. · Aug 1978
NEIVS TRACHEOTOMY RETRACTOR
K772378 · Edward Weck, Inc. · Mar 1978
HEISS RETRACTOR
K771191 · Edward Weck, Inc. · Jul 1977