510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003792Substantially Equivalent

Stryker Heated Insufflator Tube Set

Stryker Corp., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003792 is the FDA 510(k) clearance record for STRYKER HEATED INSUFFLATOR TUBE SET, a class II device, cleared for Stryker Corp. on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show one recall naming K003792.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Stryker Corp. 2590 Walsh Ave., Santa Clara CA
510(k) summary
Summary
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