The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Modified Disposable Coaxial Bipolar Pen.
| Device ID | K884347 |
| 510k Number | K884347 |
| Device Name: | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1988-12-27 |