LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH— 510(k) K940141
Substantially EquivalentMicro-Medical Devices, Inc.
FDA 510(k) clearance K940141 for LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH, Substantially Equivalent on 1994-05-19. Applicant: Micro-Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Micro-Medical Devices, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castle Pines Village, CO, US
Recent devices under product code GCJ
view allMore clearances from Micro-Medical Devices, Inc.
view all- K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
- K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
- K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
- K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
- K951894 — ACCESS EXPANSION SYSTEM
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.