Cleared Traditional

K022613 - HELIX HYDRO-JET

K022613 is the FDA 510(k) clearance for HELIX HYDRO-JET by Erbe USA, Inc.. It is a Class 2 General Hospital device (product code FQH) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K022613 · Erbe USA, Inc. · General Hospital
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Oct 2002
Decision
80d
Days
Class 2
Risk

K022613 is an FDA 510(k) clearance for the HELIX HYDRO-JET. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erbe USA, Inc. devices

Submission Details

510(k) Number K022613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2002
Decision Date October 25, 2002
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 31
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K022613.
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958 · Smith & Nephew, Inc. · Aug 2011
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
ERBE HELIX HYDRO-JET
K033590 · Erbe USA, Inc. · Jan 2004
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · Ethicon Endo-Surgery, Inc. · Dec 1997
CLEARVIEW BLOWER/MISTER
K973485 · Dlp, Inc. · Dec 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551 · Howmedica Corp. · Oct 1997