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

Endoscope, Fetal Blood Sampling (And Accessories)

21 CFR 884.1660 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGK is the FDA product code for Endoscope, Fetal Blood Sampling (And Accessories), a class II device type, regulated under 21 CFR 884.1660. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HGK
Device name
Endoscope, Fetal Blood Sampling (And Accessories)
Regulation
21 CFR 884.1660
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
1
Ingested recalls
0

Clearances, product code HGK

By decision year
1 clearance under product code HGK with a decision year between 1996 and 1996, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HGK by decision year
YearClearances
19961

Applicants with the most clearances

Product code HGK
Applicants holding the most 510(k) clearances under product code HGK
ApplicantClearances
Karl Storz Endoscopy-America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code