MOUNTABLE ENDOSCOPIC BLADE— 510(k) K080133

Substantially Equivalent

A.M. Surgical, Inc.

FDA 510(k) clearance K080133 for MOUNTABLE ENDOSCOPIC BLADE, Substantially Equivalent on 2008-03-13. Applicant: A.M. Surgical, Inc.. Device class: 1.

Clearance details

Applicant: A.M. Surgical, Inc.
Product code: Code EMF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2008-01-18
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMF

K982142 — MOUNTABLE ENDOSCOPIC KNIFE1998-12-30
K890214 — MICROSURGERY RAZOR BLADE HOLDER1989-01-27
K890215 — MICROSURGICAL SCARIFIER1989-01-27
K890217 — MICROSURGICAL KNIVES1989-01-27
K880094 — VAN-TEC ENDOPYELOTOMY KNIFE1988-02-29

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Data sourced from openFDA. This site is unofficial and independent of the FDA.