The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Endobutton Continuous Loop (cl).
| Device ID | K081098 |
| 510k Number | K081098 |
| Device Name: | ENDOBUTTON CONTINUOUS LOOP (CL) |
| Classification | Staple, Fixation, Bone |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Christina Flores |
| Correspondent | Christina Flores SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | JDR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-17 |
| Decision Date | 2008-07-16 |
| Summary: | summary |