K060908 is an FDA 510(k) clearance for the SONOHYSTEROGRAPHY BIOPSY DEVICE. This device is classified as a Cannula, Injector, Uterine, Endometrial Biopsy (Class II - Special Controls, product code PGK).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on June 29, 2006, 87 days after receiving the submission on April 3, 2006.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy.
| 510(k) Number | K060908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2006 |
| Decision Date | June 29, 2006 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PGK — Cannula, Injector, Uterine, Endometrial Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy |