The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Inscope Tissue Anchors, Knotting Elements And Tissue Anchor And Knotting Element Applier.
| Device ID | K070151 |
| 510k Number | K070151 |
| Device Name: | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Kimberly Shoemaker |
| Correspondent | Kimberly Shoemaker ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | OCW |
| Subsequent Product Code | GAW |
| Subsequent Product Code | MXW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-08-15 |
| Summary: | summary |