FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
FDA 510(k) clearance K122658 · decided 2012-12-20
Clearance details
- K-number
- K122658
- Device name
- FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
- Applicant
- Femasys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-31
- Decision date
- 2012-12-20
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- PCF
- Device class
- 2
- Regulation number
- 884.1050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Suwanee, GA, 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 |
|---|---|---|
| FEMECC ENDOCERVICAL CURETTE (K060320) | Femspec LLC | 2006-07-28 |
| EURO-MED ENDO-CURETTE (K882606) | Buckman Co., Inc. | 1988-07-25 |
| KEVOR-CURETTE (K882404) | Euro-Med Intl. | 1988-07-08 |
| DISPO-URETTE (K860796) | Roland J. Zwick, Inc. | 1986-04-08 |
Recalls involving this device
No recalls on record reference this clearance.