510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012464Substantially Equivalent

Helix Hydro-Jet

Andreas Pein Medizintechnik GmbH, Golden CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K012464 is the FDA 510(k) clearance record for HELIX HYDRO-JET, a class II device, cleared for Andreas Pein Medizintechnik GmbH on under FDA product code FQH (Lavage, Jet). FDA records list one 510(k) clearance for Andreas Pein Medizintechnik GmbH. As of , FDA records show no recalls naming K012464.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FQH Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Applicant
Andreas Pein Medizintechnik GmbH 13605 W. 7th Ave., Golden CO
510(k) summary
Summary
Third party review
No

Clearances, product code FQH

Trailing 12 months
2 clearances under product code FQH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260