THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM— 510(k) K070330
Substantially EquivalentAvantis Medical Systems, Inc.
FDA 510(k) clearance K070330 for THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM, Substantially Equivalent on 2007-04-24. Applicant: Avantis Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Avantis Medical Systems, Inc.
- Product code
- Code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code FDF
view allMore clearances from Avantis Medical Systems, Inc.
view all- K160356 — Third Eye Panoramic Auxiliary Endoscopy System - Resposable
- K140595 — THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
- K093187 — MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K091783 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
- K083180 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Adverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
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.