510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943624Substantially Equivalent

Elmed Pneumoperitoneum Needles

Henke-Sass Wolf, GmbH., Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943624 is the FDA 510(k) clearance record for ELMED PNEUMOPERITONEUM NEEDLES, a class II device, cleared for Henke-Sass, Wolf GmbH on under FDA product code FHO (Pneumoperitoneum Needle). FDA's definition for product code FHO reads: "For establishment of a pneumoperitoneum in abdomen". FDA records list 6 510(k) clearances for Henke-Sass, Wolf GmbH, from to . As of , FDA records show no recalls naming K943624.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FHO Pneumoperitoneum Needle
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Henke-Sass, Wolf GmbH Postfach 2459, Tuttlingen, DE
510(k) summary
Summary
Third party review
No

Clearances, product code FHO

Trailing 12 months

FDA records hold no clearances under product code FHO in the trailing twelve months.

FDA records show no clearances under product code FHO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260