The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc with the FDA for Tipcam 1s 3d System.
| Device ID | K162880 |
| 510k Number | K162880 |
| Device Name: | TIPCAM 1S 3D System |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-14 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551422625 | K162880 | 000 |
| 04048551416174 | K162880 | 000 |
| 04048551396018 | K162880 | 000 |
| 04048551396001 | K162880 | 000 |