Cleared Traditional

K851106 - PRATT-SMITH T FORCEPS 1830-40 PCS. SS 4...

K851106 is an FDA 510(k) clearance for PRATT-SMITH T FORCEPS 1830-40 PCS. SS 4..., 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 37-day FDA review.

K851106 · The Huxley Instrument Corp. · General & Plastic Surgery device
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Apr 1985
Decision
37d
Days
Class 1
Risk

K851106 is an FDA 510(k) clearance for the PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F. 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 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 - K851106

510(k) Number K851106 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.

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 K851106.
17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI
K851773 · Artiberia · Jun 1985
39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS
K851793 · Artiberia · Jun 1985
51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO
K851796 · Artiberia · Jun 1985
MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420
K851114 · The Huxley Instrument Corp. · Apr 1985
JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42
K851116 · The Huxley Instrument Corp. · Apr 1985
DISSECTING TWEEZER #283-72PCS. SS 410
K851170 · The Huxley Instrument Corp. · Apr 1985