ENDOSCOPIC INTRODUCER
FDA 510(k) clearance K123013 · decided 2013-03-22
Clearance details
- K-number
- K123013
- Device name
- ENDOSCOPIC INTRODUCER
- Applicant
- Novadaq Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-28
- Decision date
- 2013-03-22
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- FED
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Richmond British Columbia, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Novadaq Technologies
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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S007) | Novadaq Technologies, Inc. | 2012-02-02 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S004) | Novadaq Technologies, Inc. | 2007-09-05 |
| ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) (P950042/S003) | Novadaq Technologies, Inc. | 2005-06-30 |
| XILLIX-LIFE-LUNG (P950042/S001) | Novadaq Technologies, Inc. | 1998-07-21 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042) | Novadaq Technologies, Inc. | 1996-09-19 |