Cleared Traditional

K853015 - SELF-CENTERING BONE HOLDING FORCEPS

K853015 is an FDA 510(k) clearance for SELF-CENTERING BONE HOLDING FORCEPS, manufactured by The Huxley Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K853015 · The Huxley Instrument Corp. · General & Plastic Surgery device
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Jul 1985
Decision
12d
Days
Class 1
Risk

K853015 is an FDA 510(k) clearance for the SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 12 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 - K853015

510(k) Number K853015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1985
Decision Date July 29, 1985
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, 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 - GEN Forceps, General & Plastic Surgery

All 58
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K853015.
GRASPING FORCEP, 1.7MM
K871926 · Arthropedics, Inc. · Jun 1987
CUP BIOPSY FORCEP, 1.7MM
K871927 · Arthropedics, Inc. · Jun 1987
PILLING HEMOSTATIC CLIP APPLIER FORCEPS
K854916 · Pilling Co. · Jan 1986
IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS
K852717 · The Huxley Instrument Corp. · Jul 1985
CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
K852730 · The Huxley Instrument Corp. · Jul 1985
2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
K851728 · Artiberia · Jul 1985