Product code FSD
- Device name
- Binder, Abdominal
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5160
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Kuhn Industries | 1989-07-20 |
| K822817 | DOCE ALL-IN-THE-EAR AID | Fidelty Hearing Instruments, Inc. | 1983-01-18 |
| K810379 | EARETTE HEARING AID SEARS #8054 | Oticon Corp. | 1981-03-04 |
| K770162 | MATERNITY SUPPORTER | R.G. Moore | 1977-02-09 |
| K760772 | DISPOSABLE ABDOMINAL BINDER | Tecnol New Jersey Wound Care, Inc. | 1976-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20192253045342 | Argyle | Cardinal Health 200, LLC | 2022-12-07 |
| 20192253045304 | Argyle | Cardinal Health 200, LLC | 2022-12-07 |
| 10840200310403 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-20 |
| 10840200310427 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-20 |
| 10840200310380 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-20 |
| 20192253021049 | Kendall | Cardinal Health 200, LLC | 2021-02-15 |
| 20192253020943 | Kendall | Cardinal Health 200, LLC | 2020-12-22 |
| 20192253020875 | Kendall | Cardinal Health 200, LLC | 2020-12-11 |
| 20192253020837 | Kendall | Cardinal Health 200, LLC | 2020-11-24 |
| 18100013410380 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013410403 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013410427 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 20884527005373 | Kendall | Cardinal Health, Inc. | 2018-06-30 |
| 20884527005311 | Kendall | Cardinal Health, Inc. | 2018-06-30 |
| 10884527007448 | Devon | Cardinal Health, Inc. | 2018-06-29 |
| 10884527007455 | Devon | Cardinal Health, Inc. | 2018-06-29 |
| 20884527005380 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 10884521133914 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 20884527005328 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 20884527005410 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 10884521177352 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 20884527005403 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 20884527005366 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 20884527005359 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 20884527005342 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 20884527005335 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 10884521133907 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 10884521177321 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 10884521177338 | Kendall | Cardinal Health, Inc. | 2018-06-23 |
| 10884521177314 | Kendall | Cardinal Health, Inc. | 2016-09-24 |