The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for I/a Handpiece With Replaceable Tips.
| Device ID | K910245 |
| 510k Number | K910245 |
| Device Name: | I/A HANDPIECE WITH REPLACEABLE TIPS |
| Classification | Catheter, Irrigation |
| Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Todd Hessel |
| Correspondent | Todd Hessel SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-22 |