The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System Procedure Kit Sterilization Tray.
| Device ID | K192781 |
| 510k Number | K192781 |
| Device Name: | UroLift System Procedure Kit Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
| Contact | Brian Gall |
| Correspondent | Brian Gall NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814932020056 | K192781 | 000 |