Cleared Traditional

K991383 - HYDROCISION DEBDRIDEMENT SYSTEM

K991383 is an FDA 510(k) clearance for HYDROCISION DEBDRIDEMENT SYSTEM, manufactured by Hydrocision, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K991383 · Hydrocision, Inc. · General Hospital
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Mar 2000
Decision
345d
Days
Class 2
Risk

K991383 is an FDA 510(k) clearance for the HYDROCISION DEBDRIDEMENT 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 March 31, 2000 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hydrocision, Inc. devices

FDA 510(k) Submission Details - K991383

510(k) Number K991383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date March 31, 2000
Days to Decision 345 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
216d slower than avg
Panel avg: 129d · This submission: 345d
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 K991383.
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
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · Ethicon Endo-Surgery, Inc. · Dec 1997
CLEARVIEW BLOWER/MISTER
K973485 · Dlp, Inc. · Dec 1997