Cleared Traditional

K110958 - VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH

K110958 is an FDA 510(k) clearance for VERSAJET II HYDROSURGERY SYSTEM CONSOLE..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K110958 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
118d
Days
Class 2
Risk

K110958 is an FDA 510(k) clearance for the VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,.... Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on August 1, 2011 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K110958

510(k) Number K110958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2011
Decision Date August 01, 2011
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 40
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K110958.
The VersaJet II Hydrosurgery System
K143115 · Smith & Nephew, Inc. · Jul 2015
HY-CHLO(TM)WOUND SCRUB
K113312 · Patrin Pharma · Aug 2012
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K111313 · Alcavis Hdc, LLC · Dec 2011
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
K060782 · Smith & Nephew Wound Management · Apr 2006
ERBE HELIX HYDRO-JET
K033590 · Erbe USA, Inc. · Jan 2004