CrossBay Endometrial Tissue Sampler (ETS)
FDA 510(k) clearance K192534 · decided 2020-03-25
Clearance details
- K-number
- K192534
- Device name
- CrossBay Endometrial Tissue Sampler (ETS)
- Applicant
- Crossbay Medical
- Decision
- Substantially Equivalent
- Date received
- 2019-09-16
- Decision date
- 2020-03-25
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- HHK
- Device class
- 2
- Regulation number
- 884.1175
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Uterine Aspiration Set (K251882) | Gcmedica Enterprise Ltd.(Wuxi) | 2025-10-16 |
| RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (K240434) | Li Medical Corporation , Ltd. | 2024-09-25 |
| CrossGlide ETS Plus (K201952) | Crossbay Medical | 2020-08-05 |
| DISPOSABLE ENDOMETRIAL SUCTION CURETTE (K102847) | Jiangsu Suyun Medical Materials Co., Ltd. | 2011-04-14 |
| THE PANPAC SUCTION CURETTE (K092982) | Panpac Medical Corporation | 2010-07-26 |
| FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (K051294) | Femspec LLC | 2005-12-21 |
| ENDOMETRIAL SAMPLING SYRINGE (K040189) | Rocket Medical Plc | 2004-10-04 |
| MAS WITH OR WITHOUT SYRINGE (K021876) | Marina Medical Instruments, Inc. | 2003-04-08 |
| CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (K020628) | Bioteque America, Inc. | 2002-05-24 |
| SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (K001555) | Sims Portex , Ltd. | 2000-08-02 |
| PIPET CURET (K001545) | Milex Products, Inc. | 2000-06-15 |
| FOWLER ENDOCURETTE, MODEL CUR-XXX (K000974) | Utah Medical Products, Inc. | 2000-05-23 |
Recalls involving this device
No recalls on record reference this clearance.