The following data is part of a premarket notification filed by Incisive Surgical, Inc. with the FDA for Insorb Absorbable Staple, Model Sp-b20.
| Device ID | K033602 |
| 510k Number | K033602 |
| Device Name: | INSORB ABSORBABLE STAPLE, MODEL SP-B20 |
| Classification | Staple, Implantable |
| Applicant | INCISIVE SURGICAL, INC. 14405 21ST AVE N. SUITE 130 Plymouth, MN 55447 |
| Contact | Jim Peterson |
| Correspondent | Jim Peterson INCISIVE SURGICAL, INC. 14405 21ST AVE N. SUITE 130 Plymouth, MN 55447 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-14 |
| Decision Date | 2003-12-16 |
| Summary: | summary |