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INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF

K003717 Class II Abbreviated
Decision Date
2001-03-01
Sponsor / Applicant
Tekno Medical Optik-Chirurgie GmbH & Co.

Technical Specification

510(k) Submission ID K003717
Product Code GEI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4400
Decision Date 2001-03-01
Clearance Pathway Abbreviated

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF received FDA 510(k) clearance under submission number K003717, sponsored by Tekno Medical Optik-Chirurgie GmbH & Co.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-03-01.

Classification & Regulation

This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.