Cleared Traditional

K873505 - CUP BIOPSY FORCEPS, CURVED DOWN
(FDA 510(k) Clearance)

Nov 1987
Decision
63d
Days
Class 1
Risk

K873505 is an FDA 510(k) clearance for the CUP BIOPSY FORCEPS, CURVED DOWN. This device is classified as a Forceps (Class I - General Controls, product code HTD).

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987, 63 days after receiving the submission on August 31, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K873505 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

Device Classification

Product Code HTD — Forceps
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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