ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)— 510(k) K970882
Substantially EquivalentAmerican Medical Devices, Inc.
FDA 510(k) clearance K970882 for ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.), Substantially Equivalent on 1997-06-24. Applicant: American Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- American Medical Devices, Inc.
- Product code
- Code MPA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code MPA
view all- K253468 — Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- K242184 — Alcon 27GA Chandelier (8065000252) +2 more
- K233653 — Midfield Light Pipe, 23ga (3269.M06-00) +2 more
- K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
- K202670 — Nam illumination probe with chopper
More clearances from American Medical Devices, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.