The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical-surgitek Ultragold Plus Side-firing Urologic Laser Fiber.
| Device ID | K951714 |
| 510k Number | K951714 |
| Device Name: | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-14 |
| Decision Date | 1995-07-11 |