Cleared Traditional

K821143 - DISPOSABLE THUMB FORCEPS

K821143 is the FDA 510(k) clearance for DISPOSABLE THUMB FORCEPS by Medcare Products. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K821143 · Medcare Products · General & Plastic Surgery device
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May 1982
Decision
30d
Days
Class 1
Risk

K821143 is an FDA 510(k) clearance for the DISPOSABLE THUMB FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Medcare Products (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982 after a review of 30 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 Medcare Products devices

Submission Details

510(k) Number K821143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1982
Decision Date May 21, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 57
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K821143.
CONPHAR ALLIS FORCEPS
K821353 · Conphar, Inc. · May 1982
TUBE OCCULDING FORCEPS 7
K821288 · Conphar, Inc. · May 1982
CONPHAR FOERSTER FORCEPS
K821349 · Conphar, Inc. · May 1982
BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS
K820967 · Mill-Rose Laboratory · Apr 1982
RETRIEVAL FORCEPS W/ALLIGATOR JAWS
K820968 · Mill-Rose Laboratory · Apr 1982
BIOPSY FORCEPW W/SMALL OVAL CUPS
K820969 · Mill-Rose Laboratory · Apr 1982