Cleared Traditional

K852724 - BACKHAUS TOWEL CLAMP

K852724 is an FDA 510(k) clearance for BACKHAUS TOWEL CLAMP, manufactured by The Huxley Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K852724 · The Huxley Instrument Corp. · General & Plastic Surgery device
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Jul 1985
Decision
19d
Days
Class 1
Risk

K852724 is an FDA 510(k) clearance for the BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 15, 1985 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 The Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K852724

510(k) Number K852724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date July 15, 1985
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

GDJ Device Classification - Class 1, General Controls

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
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 - GDJ Clamp, Surgical, General & Plastic Surgery

All 15
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K852724.
SURGICAL DUCT CLAMP (VINE)
K882169 · Henley Intl. · Jun 1988
AUTO SUTURE PURSE STRING APPLIER*
K874428 · United States Surgical, A Division of Tyco Healthc · Dec 1987
TOURIQUET KIT WITH SNARE
K855144 · Dlp, Inc. · Feb 1986
17-900 TO 17-980 VARIOUS TOWEL CLAMPS
K851774 · Artiberia · Jun 1985
PROXIMATE * PSD PURSE-STRING DEVICE
K801660 · Ethicon, Inc. · Aug 1980
VESSEL OCCLUDER
K800074 · Cordis Corp. · Jan 1980