HHK · Curette, Suction, Endometrial (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1175 · Class 2
Overview
| Product Code | HHK |
|---|---|
| Device Name | Curette, Suction, Endometrial (And Accessories) |
| Regulation | 21 CFR 884.1175 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | Oct 16, 2025 | SESE |
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | Li Medical Corporation , Ltd. | Sep 25, 2024 | SESE |
| K201952 | CrossGlide ETS Plus | Crossbay Medical | Aug 5, 2020 | SESE |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | Mar 25, 2020 | SESE |
| K102847 | DISPOSABLE ENDOMETRIAL SUCTION CURETTE | Jiangsu Suyun Medical Materials Co., Ltd. | Apr 14, 2011 | SESE |
| K092982 | THE PANPAC SUCTION CURETTE | Panpac Medical Corporation | Jul 26, 2010 | SESE |
| K051294 | FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 | Femspec LLC | Dec 21, 2005 | SESE |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Rocket Medical Plc | Oct 4, 2004 | SESE |
| K021876 | MAS WITH OR WITHOUT SYRINGE | Marina Medical Instruments, Inc. | Apr 8, 2003 | SESE |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | Bioteque America, Inc. | May 24, 2002 | SESE |
| K001555 | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 | Sims Portex , Ltd. | Aug 2, 2000 | SESE |
| K001545 | PIPET CURET | Milex Products, Inc. | Jun 15, 2000 | SESE |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | Utah Medical Products, Inc. | May 23, 2000 | SESE |
| K000026 | APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER | Apple Medical Corp. | Mar 31, 2000 | SESE |
| K992926 | GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) | Ri Mos. S.R.L. | Oct 26, 1999 | SESE |
| K991895 | RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) | Ri Mos. S.R.L. | Aug 12, 1999 | SESE |
| K990387 | ENDOMETRIAL SAMPLER | U.A. Medical Products, Inc. | Apr 20, 1999 | SESE |
| K974819 | SELECTCELLS(TM) MINI | Select Medical Systems, Inc. | Mar 23, 1998 | SESE |
| K960239 | CPR D & C TRAY | Custom Pack Reliability | May 23, 1996 | SESE |
| K954097 | SELECTCELLS STANDARD | Select Medical Systems, Inc. | Nov 21, 1995 | SESE |
Top Applicants
- American Hospital Supply Corp. — 2 clearances
- Crossbay Medical — 2 clearances
- Milex Products, Inc. — 2 clearances
- Pioneer Medical, Inc. — 2 clearances
- Ri Mos. S.R.L. — 2 clearances
