Cleared Traditional

DYNACYT BIOPSY ASPIRATION DEVICE

K922919 · Buckman Co., Inc. · General & Plastic Surgery
Mar 1993
Decision
287d
Days
Class 1
Risk

About This 510(k) Submission

K922919 is an FDA 510(k) clearance for the DYNACYT BIOPSY ASPIRATION DEVICE, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on March 31, 1993, 287 days after receiving the submission on June 17, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K922919 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1992
Decision Date March 31, 1993
Days to Decision 287 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MJG — Device, Percutaneous, Biopsy
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800