Cleared Traditional

MEDNEXT 1000 DRILL

K972308 · Mednext, Inc. · General & Plastic Surgery
Aug 1997
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K972308 is an FDA 510(k) clearance for the MEDNEXT 1000 DRILL, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Mednext, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on August 20, 1997, 61 days after receiving the submission on June 20, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K972308 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1997
Decision Date August 20, 1997
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GEY — Motor, Surgical Instrument, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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