Home / 510(k) Clearances / K950712

510(k) K950712

PORTABLE ENDOSCOPY SYSTEM by Laser-Optik-Systeme GmbH & Co. KG — Product Code GCM

K950712 is an FDA 510(k) premarket notification submitted by Laser-Optik-Systeme GmbH & Co. KG for the device "PORTABLE ENDOSCOPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 1996. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Laser-Optik-Systeme GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
February 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Laser-Optik-Systeme GmbH & Co. KG

  • K972056 — STANDARD ENDOSCOPE (July 30, 1997)
  • K952028 — COLD LIGHT SOURCE LOS XL-A 100 (July 27, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)

Other clearances for product code GCM

  • K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM (May 14, 2021)
  • K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (September 28, 2009)
  • K001217 — INSIDE VIEW (July 11, 2000)
  • K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS (December 10, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (September 17, 1996)
  • K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (January 26, 1996)
  • K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (March 23, 1995)
  • K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES (March 22, 1995)
  • K931954 — THORACOSCOPE/LAPAROSCOPE (November 2, 1993)

FDA data resources