Cleared Traditional

K873512 - SERRATED GRASPING FORCEPS

K873512 is an FDA 510(k) clearance for SERRATED GRASPING FORCEPS, manufactured by Arthropedics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K873512 · Arthropedics, Inc. · General & Plastic Surgery device
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Nov 1987
Decision
63d
Days
Class 1
Risk

K873512 is an FDA 510(k) clearance for the SERRATED GRASPING FORCEPS, RIGHT. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 63 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 Arthropedics, Inc. devices

FDA 510(k) Submission Details - K873512

510(k) Number K873512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date November 02, 1987
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

Product Code HTD Forceps
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 - HTD Forceps

All 54
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K873512.
CUP BIOPSY FORCEPS, CURVED UP
K873506 · Arthropedics, Inc. · Nov 1987
SERRATED GRASPING FORCEPS, CURVED DOWN
K873510 · Arthropedics, Inc. · Nov 1987
SERRATED GRASPING FORCEPS, LEFT
K873511 · Arthropedics, Inc. · Nov 1987
SERRATED GRASPING FORCEPS, CURVED UP
K873513 · Arthropedics, Inc. · Nov 1987
RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420
K852713 · The Huxley Instrument Corp. · Jul 1985
MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420
K852715 · The Huxley Instrument Corp. · Jul 1985