510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGKClass II

Cannula, Injector, Uterine, Endometrial Biopsy

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PGK is the FDA product code for Cannula, Injector, Uterine, Endometrial Biopsy, a class II device type, regulated under 21 CFR 884.4530. FDA's definition for this code reads: "to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PGK
Device name
Cannula, Injector, Uterine, Endometrial Biopsy
FDA definition
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PGK

By decision year
2 clearances under product code PGK with a decision year between 2006 and 2014, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PGK by decision year
YearClearances
20061
20141

Applicants with the most clearances

Product code PGK
Applicants holding the most 510(k) clearances under product code PGK
ApplicantClearances
Cook Incorporated1
Crossbay Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code