The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Endo-leader.
| Device ID | K954641 |
| 510k Number | K954641 |
| Device Name: | ENDO-LEADER |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | MICROSURGE, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara MICROSURGE, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1995-12-28 |