Product code KNH
- Device name
- Laparoscopic Contraceptive Tubal Occlusion Device
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 3
- Regulation number
- 884.5380
- Review panel
- OB
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P920046S015 | Filshie Clip (Mark VI) System | Femcare , Ltd. | 2024-12-03 |
| P920046S014 | Filshie Clip (Mark VI) System | Femcare , Ltd. | 2024-09-16 |
| P920046S013 | Filshie Clip System | Femcare , Ltd. | 2023-12-18 |
| P920046S012 | Filshie Clip (Mark VI) System | Femcare , Ltd. | 2022-01-06 |
| P870076S027 | Falope Ring Band and Applicator Systems | Gyrus Acmi, Inc. | 2021-05-19 |
| P870076S026 | Falope-Ring® Band and Applicator Systems | Gyrus Acmi, Inc. | 2021-05-11 |
| P870076S025 | Falope Ring Bands | Gyrus Acmi, Inc. | 2020-07-02 |
| P870076S024 | Trocar Knife | Gyrus Acmi, Inc. | 2020-02-12 |
| P920046S011 | Filshie Clip (Mark VI) System | Femcare , Ltd. | 2019-10-09 |
| P920046S010 | Sterishot II Mini Flishie Clip Applicator | Femcare , Ltd. | 2017-05-26 |
| P870076S022 | FALOPE RING BAND AND APPLICATOR SYSTEMS | Gyrus Acmi, Inc. | 2017-02-21 |
| P920046S008 | FILSHIE CLIP(MARK VI) SYSTEM | Femcare , Ltd. | 2016-12-02 |
| P870080S002 | HULKA CLIP FOR TUBAL OCCLUSION | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| P870076S023 | Falope-Ring Band Contraceptive Tubal Occlusion System | Gyrus Acmi, Inc. | 2016-09-23 |
| P920046S009 | FILSHIE CLIP (MARK VI) SYSTEM | Femcare , Ltd. | 2016-09-09 |
| P870076S017 | FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM | Gyrus Acmi, Inc. | 2016-07-20 |
| P870076S018 | FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM | Gyrus Acmi, Inc. | 2016-03-22 |
| P870076S021 | DISPOSABLE FALOPE-RING BAND APPLICATOR KITS | Gyrus Acmi, Inc. | 2016-03-02 |
| P870076S020 | DISPOSABLE FALOPE-RING BANK APPLICATOR KITS | Gyrus Acmi, Inc. | 2016-02-09 |
| P870076S019 | DISPOSABLE FALOPE-RING BAND APPLICATOR KITS | Gyrus Acmi, Inc. | 2016-01-27 |
| P870076S016 | FALOPE-RING BAND APPLICATOR KITS | Gyrus Acmi, Inc. | 2015-02-19 |
| P870076S015 | DISPOSABLE FALOPE RING BAND APPLICATOR KITS | Gyrus Acmi, Inc. | 2014-12-04 |
| P870076S014 | FALOPE-RING BAND AND APPLICATOR SYSTEMS | Gyrus Acmi, Inc. | 2014-11-17 |
| P870076S013 | FALOPE-RING CAND AND APPLICATOR SYSTEMS | Gyrus Acmi, Inc. | 2012-10-26 |
| P870076S012 | DISPOSABLE FALOPE-RING BAND APPLICATOR KITS | Gyrus Acmi, Inc. | 2012-07-05 |
| P070022S028 | ADIANA PERMANENT CONTRACEPTION SYSTEM | Hologic, Inc. | 2012-03-28 |
| P070022S025 | ADIANA CONTRACEPTION SYSTEM | Hologic, Inc. | 2012-03-20 |
| P070022S026 | ADIANA PERMANENT CONTRACEPTION SYSTEM | Hologic, Inc. | 2012-02-09 |
| P070022S024 | ADIANA PERMANENT CONTRACEPTION SYSTEM | Hologic, Inc. | 2011-11-23 |
| P070022S014 | ADIANA PERMANENT CONTRACEPTION SYSTEM | Hologic, Inc. | 2011-09-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055515602244 | Filshie® Clips (Femcare) | FEMCARE LIMITED | 2025-02-28 |
| 25055515602262 | Filshie® Clips | FEMCARE LIMITED | 2025-02-28 |
| 25055515602248 | Filshie® Clips (Femcare) | FEMCARE LIMITED | 2025-02-28 |
| 00821925028913 | Gyrus ACMI | Gyrus ACMI, LLC | 2024-07-12 |
| 00821925028869 | FALOPE-RING | Gyrus ACMI, LLC | 2024-07-12 |
| 15055515602265 | Filshie® Clips | FEMCARE LIMITED | 2023-05-15 |
| 05055515602268 | Filshie® Clips | FEMCARE LIMITED | 2023-05-15 |
| 15055515602326 | Sterishot | FEMCARE LIMITED | 2023-05-15 |
| 15055515602340 | Sterishot (Femcare) for Minilaparotomy | FEMCARE LIMITED | 2023-05-15 |
| 00868029000391 | Head Coil (Receive Only) | VIEWRAY INCORPORATED | 2022-05-06 |
| 15055515602371 | Sterishot II Elite Kit | FEMCARE LIMITED | 2021-01-14 |
| 15055515602289 | Filshie® Clip Applicator, 7.3mm SI (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602296 | Filshie® Clip Applicator, 7mm DI (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602302 | Filshie® Clip Applicator, 5mm SI (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602333 | Sterishot II Kit | FEMCARE LIMITED | 2019-02-01 |
| 15055515602357 | Sterishot (Femcare) for Minilaparotomy | FEMCARE LIMITED | 2019-02-01 |
| 15055515602241 | Filshie® Clips (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602234 | Filshie® Clips (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602272 | Filshie® Clip Applicator, Minilap (Femcare) | FEMCARE LIMITED | 2019-02-01 |
| 15055515602197 | Sterishot Kit for Minilaparotomy (CSI) | FEMCARE LIMITED | 2018-12-06 |
| 25055515602194 | Sterishot | FEMCARE LIMITED | 2018-12-06 |
| 05055515602114 | Filshie® Clips | FEMCARE LIMITED | 2017-06-22 |
| 25055515602187 | Sterishot | FEMCARE LIMITED | 2017-06-21 |
| 15055515602180 | Sterishot II Kit (CSI) | FEMCARE LIMITED | 2017-06-21 |
| 15055515600759 | Sterishot | FEMCARE LIMITED | 2016-12-21 |
| 25055515600756 | Sterishot | FEMCARE LIMITED | 2016-12-21 |
| 05055515602121 | Filshie® Clips | FEMCARE LIMITED | 2014-09-25 |
| 05055515602138 | Filshie® Clip Applicator, 5mm SI | FEMCARE LIMITED | 2014-09-25 |
| 05055515602145 | Filshie® Clip Applicator, 7mm DI (CSI) | FEMCARE LIMITED | 2014-09-25 |
| 05055515602152 | Filshie® Clip Applicator, 7.3mm Single Incision | FEMCARE LIMITED | 2014-09-25 |