ReShape Calibration Tubes™ - B-2017
2025-08-01
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013508647 | 3013508647 | Medtimo, Inc. | 1 | Y | 2026-01-01 | 7625 Golden Triangle Dr Ste G Eden Prairie MN US 55344 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850007764203 | Gastric Balloon Suction Catheter - Bio Gastric Balloon Suction Catheter | 844-937-7374 | CustomerService@ReShapelifesci.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 206745 | 1160669587 | P160001 | OBALON BALLOON SYSTEM | LTI | 2016-09-08 |
| 206745 | 1978019213 | P130019 | MAESTRO RECHARGEABLE SYSTEM | PIM | 2015-01-14 |
| 206745 | 1250505105 | P000008 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM | LTI | 2001-06-05 |
| 206745 | 1662269577 | K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | KNT | 2024-05-16 |
| 206745 | 1985148714 | K230131 | ReShape Calibration Tubes | KNT | 2023-02-15 |
| 206745 | 1569552643 | K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | KNT | 2022-07-28 |
| 206745 | 2067464875 | K220455 | Lap-Band System Calibration Tube | KNT | 2022-06-07 |
| 206745 | 1583112105 | K130424 | STIMEL-03 | IPF | 2013-07-11 |
| 206745 | 1301257265 | K002838 | GASTRIC SUCTION AND DRAINAGE CATHETER | KNT | 2001-07-09 |
| 206745 | 1595920141 |
2025-08-01
2023-03-16
2023-03-16
2023-03-16
2020-11-01
2016-12-12
2016-12-22
2016-12-26
2017-07-11
2018-07-11
2019-02-20
2018-08-09
2024-01-22
2024-01-22
2024-01-22
2024-01-22
2024-01-22
2021-04-01
2021-04-01
2021-02-01
2021-02-01
2021-02-01
2021-02-01
2021-01-01
2016-12-22
2016-12-26
2016-12-26
2017-07-11
2017-07-11
2019-02-20
2019-02-20
2019-02-20
2019-02-20
2019-02-20
2019-02-20
2019-02-20
2019-02-20