FDA product code HGK: Endoscope, Fetal Blood Sampling (And Accessories)

HGK is the FDA product code for endoscope, fetal blood sampling (and accessories). It is a Class II device, regulated under 21 CFR 884.1660 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HGK. The average 510(k) review took 260 days (median 260).

Classification

Compare with all 510(k) review times · Search every HGK clearance

Top HGK applicants

Most recent HGK clearances

Recalls for HGK devices

openFDA lists no recalls for product code HGK.

Frequently asked questions

What is FDA product code HGK?

HGK is the FDA product code for endoscope, fetal blood sampling (and accessories). It is a Class II device, regulated under 21 CFR 884.1660 and reviewed by the Obstetrics and Gynecology panel.

What device class is HGK?

Class II, regulation 21 CFR 884.1660. Typical premarket route: 510(k).

How long does a 510(k) take for product code HGK?

Across 1 cleared submissions the average was 260 days from receipt to decision (median 260).

Which companies have the most HGK clearances?

KARL STORZ Endoscopy-America, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code HGK
• Run a recall and safety report across every HGK manufacturer
• Watch product code HGK 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.

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