FDA product code PGK: Cannula, Injector, Uterine, Endometrial Biopsy
PGK is the FDA product code for cannula, injector, uterine, endometrial biopsy. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under PGK, from 2 different applicants. The average 510(k) review took 120 days (median 120).
Definition
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Injector, Uterine, Endometrial Biopsy |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PGK clearance
Top PGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crossbay Medical, Inc. | 1 | 2014-03-19 |
| Cook Urological, Inc. | 1 | 2006-06-29 |
Most recent PGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133144 | Crossbay Medical, Inc. | SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE | 2014-03-19 | 153 |
| K060908 | Cook Urological, Inc. | SONOHYSTEROGRAPHY BIOPSY DEVICE | 2006-06-29 | 87 |
Recalls for PGK devices
openFDA lists no recalls for product code PGK.
Frequently asked questions
What is FDA product code PGK?
PGK is the FDA product code for cannula, injector, uterine, endometrial biopsy. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is PGK?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGK?
Across 2 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most PGK clearances?
Crossbay Medical, Inc. (1); Cook Urological, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGK
- Run a recall and safety report across every PGK manufacturer
- Watch product code PGK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times