Cleared Traditional

SPACER

K925870 · Bip USA, Inc. · General & Plastic Surgery
May 1993
Decision
181d
Days
Class 1
Risk

About This 510(k) Submission

K925870 is an FDA 510(k) clearance for the SPACER, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on May 19, 1993, 181 days after receiving the submission on November 19, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K925870 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1992
Decision Date May 19, 1993
Days to Decision 181 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

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