510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950712Substantially Equivalent

Portable Endoscopy System

Laser-Optik-Systeme GmbH & Co. KG, Mainz, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950712 is the FDA 510(k) clearance record for PORTABLE ENDOSCOPY SYSTEM, a class II device, cleared for Laser-Optik-Systeme GmbH & Co. KG on under FDA product code GCM (Endoscope, Rigid). FDA records list 7 510(k) clearances for Laser-Optik-Systeme GmbH & Co. KG, from to . As of , FDA records show no recalls naming K950712.

Clearance record

Decision date
Received
(455 days to decision)
Product code
GCM Endoscope, Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laser-Optik-Systeme GmbH & Co. KG Am Sagewerk 11, Mainz, DE
510(k) summary
Statement
Third party review
No

Clearances, product code GCM

Trailing 12 months

FDA records hold no clearances under product code GCM in the trailing twelve months.

FDA records show no clearances under product code GCM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260