The following data is part of a premarket notification filed by Novadaq Technologies Ulc (now A Part Of Stryker) with the FDA for Pinpoint Endoscopic Fluorescence Imaging System.
| Device ID | K182606 |
| 510k Number | K182606 |
| Device Name: | PINPOINT Endoscopic Fluorescence Imaging System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Novadaq Technologies ULC (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Contact | Agatha Szeliga |
| Correspondent | Agatha Szeliga Novadaq Technologies ULC (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327502801 | K182606 | 000 |
| 10858701006176 | K182606 | 000 |