Product code HHK
- Device name
- Curette, Suction, Endometrial (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1175
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | 2025-10-16 |
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | Li Medical Corporation , Ltd. | 2024-09-25 |
| K201952 | CrossGlide ETS Plus | Crossbay Medical | 2020-08-05 |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | 2020-03-25 |
| K102847 | DISPOSABLE ENDOMETRIAL SUCTION CURETTE | Jiangsu Suyun Medical Materials Co., Ltd. | 2011-04-14 |
| K092982 | THE PANPAC SUCTION CURETTE | Panpac Medical Corporation | 2010-07-26 |
| K051294 | FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 | Femspec LLC | 2005-12-21 |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Rocket Medical Plc | 2004-10-04 |
| K021876 | MAS WITH OR WITHOUT SYRINGE | Marina Medical Instruments, Inc. | 2003-04-08 |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | Bioteque America, Inc. | 2002-05-24 |
| K001555 | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 | Sims Portex , Ltd. | 2000-08-02 |
| K001545 | PIPET CURET | Milex Products, Inc. | 2000-06-15 |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | Utah Medical Products, Inc. | 2000-05-23 |
| K000026 | APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER | Apple Medical Corp. | 2000-03-31 |
| K992926 | GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) | Ri Mos. S.R.L. | 1999-10-26 |
| K991895 | RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) | Ri Mos. S.R.L. | 1999-08-12 |
| K990387 | ENDOMETRIAL SAMPLER | U.A. Medical Products, Inc. | 1999-04-20 |
| K974819 | SELECTCELLS(TM) MINI | Select Medical Systems, Inc. | 1998-03-23 |
| K960239 | CPR D & C TRAY | Custom Pack Reliability | 1996-05-23 |
| K954097 | SELECTCELLS STANDARD | Select Medical Systems, Inc. | 1995-11-21 |
| K952652 | MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER | Medscand (Usa), Inc. | 1995-09-15 |
| K915491 | CURELLE | Bioteque Corp. | 1992-11-04 |
| K914220 | PIONEER PRO-PUMP | Pioneer Medical, Inc. | 1992-03-04 |
| K914241 | PIONEER PRO-PUMP DUAL CONTROL | Pioneer Medical, Inc. | 1992-03-04 |
| K881456 | PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE | Laboratoire Ccd C/O Washington Regulatory Services | 1988-10-14 |
| K875084 | CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE | Cabot Medical Corp. | 1988-02-08 |
| K872908 | ENDOMETRIAL SAMPLER | Zinnanti Surgical Instruments, Inc. | 1987-10-20 |
| K853216 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 | Gyneco, Inc. | 1986-04-02 |
| K854415 | ENDOMETRIAL PIPELLE | Unimar, Inc. | 1986-03-13 |
| K823080 | VAKUTAGE | Weston, Copco, Inc. | 1982-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810142352338 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-08 |
| 04719894432335 | Bioteque | Bioteque Taiwan Ltd. | 2024-12-06 |
| 04719894432311 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432328 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432403 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894433363 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 10888277632165 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-01 |
| 10888277632158 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-01 |
| 10888277632141 | Medline | MEDLINE INDUSTRIES, INC. | 2021-02-01 |
| 10381780177036 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-04-14 |
| 00821925030961 | BERKELEY | Gyrus ACMI, LLC | 2016-10-13 |
| 00821925037489 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925030954 | Gyrus ACMI | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037465 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037472 | Gyrus ACMI | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037526 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037496 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037502 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037519 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925037991 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925038004 | Berkeley Vacurette | Gyrus ACMI, LLC | 2016-10-11 |
| 00821925030947 | Dolphin | Gyrus ACMI, LLC | 2016-10-07 |
| H671CUR1200 | EndoCurette | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671CUR1000 | EndoCurette | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| D6911030314 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |
| D6911030313 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |
| D6911030312 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |
| 10381780169956 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-13 |
| 10381780169949 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-13 |
| 10885380121791 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-22 |