The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Inscope Multi-clip Applier, Models In22321, In23321.
| Device ID | K051950 |
| 510k Number | K051950 |
| Device Name: | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 |
| Classification | Ligator, Esophageal |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Kimberly Shoemaker |
| Correspondent | Kimberly Shoemaker ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | MND |
| Subsequent Product Code | FHN |
| Subsequent Product Code | HBT |
| Subsequent Product Code | MCH |
| Subsequent Product Code | OCW |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-10-07 |
| Summary: | summary |