The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Endoscopic Introducer.
| Device ID | K123013 |
| 510k Number | K123013 |
| Device Name: | ENDOSCOPIC INTRODUCER |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | NOVADAQ TECHNOLOGIES, INC. 13155 DELF PLACE, UNIT 250 Richmond, British Columbia, CA V6v 2a2 |
| Contact | Tim Verspagen |
| Correspondent | Tim Verspagen NOVADAQ TECHNOLOGIES, INC. 13155 DELF PLACE, UNIT 250 Richmond, British Columbia, CA V6v 2a2 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-03-22 |
| Summary: | summary |