Cleared Traditional

K143115 - The VersaJet II Hydrosurgery System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143115 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
258d
Days
Class 2
Risk

K143115 is an FDA 510(k) clearance for the The VersaJet II Hydrosurgery System. 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 July 15, 2015 after a review of 258 days - an extended review 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: 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

Submission Details

510(k) Number K143115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2014
Decision Date July 15, 2015
Days to Decision 258 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
130d slower than avg
Panel avg: 128d · This submission: 258d
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 52
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K143115.
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996 · Becton, Dickinson and Company (BD) · Feb 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · Bd · Feb 2026
ERBEJET® 2 System
K231023 · Erbe Elektromedizin GmbH · Jun 2023
VERSAJET Hydrosurgery System (III)
K220964 · Smith & Nephew Medical Limited · May 2023
BD Surgiphor Antimicrobial Irrigation System
K213616 · Becton, Dickinson and Company · Mar 2022