Product code HGE
- Device name
- Amniotome
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951148 | OBSTI-HOOK | Onli | 1995-06-09 |
| K926425 | AMNIPERF(TM) | Raymart Development Co. | 1994-03-07 |
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | Epcom Medical Systems, Inc. | 1991-05-09 |
| K871087 | S.C.M.T. PERFORATOR | Salt Creek Medical Technologies | 1987-03-23 |
| K850758 | AMNIGLOVE & AMNICOT | Go Medical Industries Pty. , Ltd. | 1985-04-15 |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | Imm Enterprises , Ltd. | 1983-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049047043737 | Gimmi | Gimmi GmbH | 2025-05-13 |
| M803020301 | MedGyn Disposable Amnio Hook | MEDGYN PRODUCTS, INC. | 2024-04-30 |
| 00849233010505 | BUSSE HOSPITAL DISPOSABLES | ROBERT BUSSE & CO., INC. | 2023-08-09 |
| 10849233010502 | BUSSE HOSPITAL DISPOSABLES | ROBERT BUSSE & CO., INC. | 2023-08-09 |
| 07898506815289 | Quinelato | Schobell Industrial Ltda | 2023-07-05 |
| 00840113231485 | Amnihook Amniotic Membrane Perforator | ASPEN SURGICAL PRODUCTS, INC. | 2023-02-27 |
| 00888937014761 | mityhook | Coopersurgical, Inc. | 2022-12-01 |
| 00749756166362 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-12 |
| 00749756166379 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-12 |
| 50749756166367 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-12 |
| 50749756166374 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-12 |
| 10767056096018 | Mabis DMI | D-M-S HOLDINGS, INC. | 2021-05-19 |
| 10827002343129 | ObstiHook | COOK INCORPORATED | 2020-10-02 |
| 00827002343122 | ObstiHook | COOK INCORPORATED | 2020-10-02 |
| H671AR1000 | AROM-COT | UTAH MEDICAL PRODUCTS, INC. | 2020-06-04 |
| H671AR2000 | AROM-COT | UTAH MEDICAL PRODUCTS, INC. | 2020-06-04 |
| 04038653155002 | AESCULAP | Aesculap AG | 2020-05-08 |
| H8343022600 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| 10381780506706 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| 09350902000211 | Amnicot | GO MEDICAL INDUSTRIES PTY. LTD. | 2016-09-24 |
| 09350902000174 | Amnicot | GO MEDICAL INDUSTRIES PTY. LTD. | 2016-09-24 |