The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Disposable Coaxial Bipolar Pen P/n 00150.
| Device ID | K880951 |
| 510k Number | K880951 |
| Device Name: | DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-04-13 |