Cleared Special

K011612 - MODIFICATION TO HYDROCISION DEBRIDEMENT...

K011612 is an FDA 510(k) clearance for MODIFICATION TO HYDROCISION DEBRIDEMENT..., manufactured by Hydrocision, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Special 510(k) pathway after a 28-day FDA review.

K011612 · Hydrocision, Inc. · General Hospital
Download Printable Device Report (PDF)
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Jun 2001
Decision
28d
Days
Class 2
Risk

K011612 is an FDA 510(k) clearance for the MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hydrocision, Inc. devices

FDA 510(k) Submission Details - K011612

510(k) Number K011612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date June 22, 2001
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K011612.
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K973485 · Dlp, Inc. · Dec 1997