Cleared Traditional

K851108 - VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 ...

K851108 is an FDA 510(k) clearance for VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 ..., manufactured by The Huxley Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K851108 · The Huxley Instrument Corp. · General & Plastic Surgery device
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Apr 1985
Decision
37d
Days
Class 1
Risk

K851108 is an FDA 510(k) clearance for the VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 37 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 The Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K851108

510(k) Number K851108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date April 25, 1985
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 K851108.
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
K852530 · The Huxley Instrument Corp. · Jun 1985
21-450 GELPI RETRACTOR
K851776 · Artiberia · Jun 1985
FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420
K851115 · The Huxley Instrument Corp. · Apr 1985
INSTRUMENTS FOR MICRO ANASTOMOSIS
K843100 · Downs Surgical , Ltd. · Sep 1984
SURGICAL RETRACTORS-VARIOUS
K841009 · Premier Dental Products Co. · May 1984