SONOHYSTEROGRAPHY BIOPSY DEVICE
FDA 510(k) clearance K060908 · decided 2006-06-29
Clearance details
- K-number
- K060908
- Device name
- SONOHYSTEROGRAPHY BIOPSY DEVICE
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-03
- Decision date
- 2006-06-29
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PGK
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, 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 |
|---|---|---|
| SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (K133144) | Crossbay Medical, Inc. | 2014-03-19 |
Recalls involving this device
No recalls on record reference this clearance.