The following data is part of a premarket notification filed by Reshape Lifesciences with the FDA for Gastrointestinal Boundary Identifier (gibi Hd).
| Device ID | K221898 |
| 510k Number | K221898 |
| Device Name: | Gastrointestinal Boundary Identifier (GIBI HD) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ReShape Lifesciences 1001 Calle Amanecer San Clemente, CA 92673 |
| Contact | Michelle Ravert |
| Correspondent | Michelle Ravert ReShape Lifesciences 1001 Calle Amanecer San Clemente, CA 92673 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007764234 | K221898 | 000 |
| 00850007764227 | K221898 | 000 |
| 00850007764210 | K221898 | 000 |