510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792639Substantially Equivalent

H-H Shunt Introducer

Holter-Hausner Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792639 is the FDA 510(k) clearance record for H-H SHUNT INTRODUCER, a class I device, cleared for Holter-Hausner Intl. on under FDA product code GYK (Instrument, Shunt System Implantation). FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K792639.

Clearance record

Decision date
Received
(11 days to decision)
Product code
GYK Instrument, Shunt System Implantation
Regulation
21 CFR 882.4545
Device class
Class I
Review panel
Neurology
Applicant
Holter-Hausner Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GYK

Trailing 12 months

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

FDA records show no clearances under product code GYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYK, 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