Cleared Traditional

SCALPEL HANDLE

K890242 · Kinetic Medical Products · General & Plastic Surgery
Jan 1989
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K890242 is an FDA 510(k) clearance for the SCALPEL HANDLE, a Handle, Scalpel (Class I — General Controls, product code GDZ), submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989, 9 days after receiving the submission on January 18, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K890242 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDZ — Handle, Scalpel
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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