The following data is part of a premarket notification filed by Interlace Medical, Inc. with the FDA for Surgisure Tissue Removal System.
| Device ID | K103741 |
| 510k Number | K103741 |
| Device Name: | SURGISURE TISSUE REMOVAL SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTERLACE MEDICAL, INC. 135 NEWBURY STREET Framingham, MA 01701 |
| Contact | John J Vozella |
| Correspondent | John J Vozella INTERLACE MEDICAL, INC. 135 NEWBURY STREET Framingham, MA 01701 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-03-02 |
| Summary: | summary |