EURO-MED ENDO-CURETTE
FDA 510(k) clearance K882606 · decided 1988-07-25
Clearance details
- K-number
- K882606
- Device name
- EURO-MED ENDO-CURETTE
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-24
- Decision date
- 1988-07-25
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- PCF
- Device class
- 2
- Regulation number
- 884.1050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Martinez, 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 |
|---|---|---|
| FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 (K122658) | Femasys, Inc. | 2012-12-20 |
| FEMECC ENDOCERVICAL CURETTE (K060320) | Femspec LLC | 2006-07-28 |
| 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.