510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090652Substantially Equivalent

Alpha Duo Lap Insufflator

Hippokratec GmbH, Miebach, Bavaria, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090652 is the FDA 510(k) clearance record for ALPHA DUO LAP INSUFFLATOR, a class II device, cleared for Hippokratec GmbH on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list one 510(k) clearance for Hippokratec GmbH. As of , FDA records show no recalls naming K090652.

Clearance record

Decision date
Received
(198 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hippokratec GmbH Am Windfeld 36, Miebach, Bavaria, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260