The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Cst-5000 Video Cystoscope With Endosheath System.
| Device ID | K072180 |
| 510k Number | K072180 |
| Device Name: | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | FAJ |
| Subsequent Product Code | FED |
| Subsequent Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485003173 | K072180 | 000 |
| 00874485000943 | K072180 | 000 |
| 00874485001278 | K072180 | 000 |
| 00874485002275 | K072180 | 000 |
| 00874485002565 | K072180 | 000 |
| 00874485002572 | K072180 | 000 |
| 00874485002800 | K072180 | 000 |
| 00874485002824 | K072180 | 000 |
| 00874485002961 | K072180 | 000 |
| 00874485002978 | K072180 | 000 |
| 00874485003166 | K072180 | 000 |
| 00874485000882 | K072180 | 000 |