Cleared Traditional

K060782 - VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE

K060782 is an FDA 510(k) clearance for VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE, manufactured by Smith & Nephew Wound Management. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K060782 · Smith & Nephew Wound Management · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
21d
Days
Class 2
Risk

K060782 is an FDA 510(k) clearance for the VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Smith & Nephew Wound Management (Largo, US). The FDA issued a Cleared decision on April 12, 2006 after a review of 21 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 Smith & Nephew Wound Management devices

FDA 510(k) Submission Details - K060782

510(k) Number K060782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date April 12, 2006
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K060782.
The VersaJet II Hydrosurgery System
K143115 · Smith & Nephew, Inc. · Jul 2015
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
HELIX HYDRO-JET
K022613 · Erbe USA, Inc. · Oct 2002
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568 · Chase Medical, Inc. · Jan 1998