CYTOPREP
FDA 510(k) clearance K983181 · decided 1998-11-16
Clearance details
- K-number
- K983181
- Device name
- CYTOPREP
- Applicant
- Cytoprep Inc. Est.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-11
- Decision date
- 1998-11-16
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HHI
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Eschen, LI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
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| BERKELEY V-10 VACUUM CURETTAGE SYSTEM (K030935) | Acmi Corporation | 2003-06-23 |
| MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (K931205) | Baxter Healthcare Corp | 1994-03-15 |
| CYTOSMEAR BRUSH (K904160) | Brooke Intl. | 1990-11-02 |
| CANNULA, SUCTION UTERINE (K900641) | Williams Specialty Products, Inc. | 1990-03-30 |
| SWIVEL ADAPTER (K900642) | Williams Specialty Products, Inc. | 1990-03-19 |
| SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (K880734) | Personal Products Co. | 1988-04-25 |
| CANNULA AND GENERAL PURPOSE ASPIRATOR (K873552) | Cosmedtech, Inc. | 1987-11-25 |
| COSMEDTECH GENERAL ASPIRATOR (K870574) | Cosmedtech, Inc. | 1987-03-05 |
| COSMEDTECH CANNULA (K870560) | Cosmedtech, Inc. | 1987-03-04 |
| LS3000 CANNULA UTERINE SUCTION (K862476) | Engineering, Inc. | 1986-07-18 |
| GYNASPYR VACUUM CURETTAGE UNIT (K850312) | Roseburg SA | 1985-02-28 |
Recalls involving this device
No recalls on record reference this clearance.