The following data is part of a premarket notification filed by Incisive Surgical, Inc. with the FDA for Insorb Absorbable Staple, Model 1020.
| Device ID | K061784 |
| 510k Number | K061784 |
| Device Name: | INSORB ABSORBABLE STAPLE, MODEL 1020 |
| Classification | Staple, Implantable |
| Applicant | INCISIVE SURGICAL, INC. 14405-21ST AVE. NORTH Plymouth, MN 55447 |
| Contact | James Peterson |
| Correspondent | James Peterson INCISIVE SURGICAL, INC. 14405-21ST AVE. NORTH 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 | 2006-06-26 |
| Decision Date | 2006-07-26 |
| Summary: | summary |