Cleared Traditional

VAN-TEC ENDOPYELOTOMY KNIFE

K880094 · Van-Tec, Inc. · General & Plastic Surgery
Feb 1988
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K880094 is an FDA 510(k) clearance for the VAN-TEC ENDOPYELOTOMY KNIFE, a Knife, Surgical (Class I — General Controls, product code EMF), submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on February 29, 1988, 48 days after receiving the submission on January 12, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K880094 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1988
Decision Date February 29, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code EMF — Knife, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800