PROBET (TM)
FDA 510(k) clearance K903002 · decided 1991-04-05
Clearance details
- K-number
- K903002
- Device name
- PROBET (TM)
- Applicant
- Gynopharma, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-09
- Decision date
- 1991-04-05
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- HFF
- Device class
- 2
- Regulation number
- 884.1060
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Princeton, NJ, 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 |
|---|---|---|
| ECHOSAMPLER (K041237) | Gynetics Medical Products NV | 2004-09-08 |
| WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (K902693) | Wallach Surgical Devices, Inc. | 1991-01-31 |
| ENDOSCANN (K831212) | Axcan Scientific Corp. | 1984-06-15 |
| ACCURETTE (K820641) | Axcan Scientific Corp. | 1982-06-22 |
Recalls involving this device
No recalls on record reference this clearance.