Cleared Traditional

K220964 - VERSAJET Hydrosurgery System (III) (FDA 510(k) Clearance)

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

K220964 · Smith & Nephew Medical Limited · General & Plastic Surgery device

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May 2023

Decision

410d

Days

Class 2

Risk

K220964 is an FDA 510(k) clearance for the VERSAJET Hydrosurgery System (III). Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on May 16, 2023 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5475 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number	K220964 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2022
Decision Date	May 16, 2023
Days to Decision	410 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

296d slower than avg

Panel avg: 114d · This submission: 410d

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 & Plastic Surgery devices follow this clearance model.