RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
FDA 510(k) clearance K062707 · decided 2006-12-08
Clearance details
- K-number
- K062707
- Device name
- RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
- Applicant
- Innovative Endoscopy Components, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-12-08
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FGB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ft. Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innovative Endoscopy Components
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.