FDA Product Code
FDA Product Code PGK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133144 | SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE | Crossbay Medical, Inc. | 2014-03-19 | Traditional | PDF ↗ |
| K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE | Cook Urological, Inc. | 2006-06-29 | Traditional | PDF ↗ |
Product code PGK · Class II · Obstetrics/Gynecology. Data: openFDA.