Portable Endoscopy System
FDA 510(k) K950712 · Laser-Optik-Systeme GmbH & Co. KG
510(k) numberK950712
Submission
- Device name
- Portable Endoscopy System
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
Mainz, DE - Received
- February 14, 1995
- Decision date
- May 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCM – Endoscope, Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | Richard Wolf Medical Instruments Corporation | 05/14/2021SE |
| K083840 | Msi Medserv International-Rigid EndoscopeGCM · Traditional | Msi Medserv International Deutschland GmbH | 09/28/2009SE |
| K001217 | Inside ViewGCM · Traditional | Monadnock Optics, Inc. | 07/11/2000SE |
| K993103 | ENDOSCOPES,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…GCM · Traditional | Richard Wolf Medical Instruments Corp. | 12/10/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | Omnisonics Medical Technologies | 12/06/1999SE |
| K962393 | Ksea Set for Endoscopic Assisted IntubationGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | Ethicon Endo-Surgery, Inc. | 01/26/1996SE |
| K935235 | Endoscopy System for Facial Plastic SurgeryGCM · Traditional | Smith & Nephew Richards, Inc. | 03/23/1995SE |
| K945889 | Karl Storz Plastic Surgery AccessoriesGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1995SE |
| K931954 | Thoracoscope/LaparoscopeGCM · Traditional | Surgical Technologies, Inc. | 11/02/1993SE |
More from Surgical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992540 | Xenon Light Source Pes 1GCT · Traditional | 09/14/1999SE |
| K972056 | Standard EndoscopeGCJ · Traditional | 07/30/1997SE |
| K953419 | Los 3D Vision 100GCJ · Traditional | 02/08/1996SE |
| K952028 | Cold Light Source Los Xl-A 100GCT · Traditional | 07/27/1995SE |
| K951829 | Cold Light Source Los 150EQH · Traditional | 07/10/1995SE |
| K930965 | Los 3D Vision 100GCJ · Traditional | 04/11/1994SE |
Questions and answers
When was Portable Endoscopy System cleared by the FDA?
Portable Endoscopy System (K950712) received a 510(k) decision of Substantially Equivalent on May 14, 1996, 455 days after the submission was received.
What is the product code of K950712?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.