510(k) K021876
- Device
- MAS WITH OR WITHOUT SYRINGE
- Applicant
- MARINA MEDICAL INSTRUMENTS, INC.
- 510(k) number
- K021876
- Product code
- HHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-08
- Date received
- 2002-06-07
- Regulation
- 884.1175
- Classification name
- Curette, Suction, Endometrial (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY MANSOUR
- Address
- 1308 Morningside Park Dr. Alpharetta GA US 30022 30022
FDA Registration Numbers#
- 3010155661
- 1423537
- 1450908
- 3018503755
- 1721686
- 2029275
- 3003418325
- 1519132
- 3007728276
- 3003968049
- 1718873
- 1216677
- 2246552
- 3032109
- 1921846
- 3005136445
- 8044099
- 3003790304
- 3007513241
- 9612445
- 3003717263
- 3030446844
- 3006131984
- 3007137643
- 3004111573
- 3005987240
- 3024860690
- 3009881188
- 3011050570
- 2183650
- 2953359
- 3009750712
- 3005925370
- 3010131137
- 3009513193
- 3025325116
- 3011137372
- 3007156625
- 1319639
- 3012494290
- 9710641
- 3013557562
- 1222779
- 1061124
- 3008367216
- 3008007615
- 3043226252
- 3010041511
- 3014615028
- 8030672
Source Documents#
Other 510(k) Records For Product Code HHK #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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