PORTABLE ENDOSCOPY SYSTEM— 510(k) K950712
Substantially EquivalentLaser-Optik-Systeme GmbH & Co. KG
FDA 510(k) clearance K950712 for PORTABLE ENDOSCOPY SYSTEM, Substantially Equivalent on 1996-05-14. Applicant: Laser-Optik-Systeme GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
- Product code
- Code GCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mainz, DE
Recent devices under product code GCM
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- K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
- K001217 — INSIDE VIEW
- K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
- K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR
More clearances from Laser-Optik-Systeme GmbH & Co. KG
view allAdverse events under product code GCM
product code GCM- Malfunction
- 1,233
- Total
- 1,233
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.