510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031014Substantially Equivalent

Hi-Flo Therme Pneu 45, Wisap #7083, 7083V

Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH, Sauerlach, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031014 is the FDA 510(k) clearance record for HI-FLO THERME PNEU 45, WISAP #7083, 7083V, a class II device, cleared for Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 9 510(k) clearances for Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, from to . As of , FDA records show no recalls naming K031014.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh Rudolf-Diesel-Ring 20, Sauerlach, DE
510(k) summary
Statement
Third party review
No

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