Cleared Traditional

K873124 - ANCHOR BIOPSY NEEDLE (FDA 510(k) Clearance)

Sep 1987
Decision
29d
Days
Class 1
Risk

K873124 is an FDA 510(k) clearance for the ANCHOR BIOPSY NEEDLE. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).

Submitted by Anchor Products Co. (Addison, US). The FDA issued a Cleared decision on September 8, 1987, 29 days after receiving the submission on August 10, 1987.

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

Submission Details

510(k) Number K873124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date September 08, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GAA — Needle, Aspiration And Injection, Disposable
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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