RIGID FIBEROPITC ENDOSCOPE— 510(k) K844769
Substantially EquivalentMicrovasive
FDA 510(k) clearance K844769 for RIGID FIBEROPITC ENDOSCOPE, Substantially Equivalent on 1985-01-15. Applicant: Microvasive. Device class: 2.
Clearance details
- Applicant
- Microvasive
- 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
- Milford, MA, US
Recent devices under product code GCM
view all- K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
- 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 Microvasive
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.