Cleared Traditional

K914177 - HYDRODISECTOR

K914177 is an FDA 510(k) clearance for HYDRODISECTOR, manufactured by Spiess Design, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K914177 · Spiess Design, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Nov 1991
Decision
72d
Days
Class 2
Risk

K914177 is an FDA 510(k) clearance for the HYDRODISECTOR. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Spiess Design, Inc. (Northbrook, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spiess Design, Inc. devices

FDA 510(k) Submission Details - K914177

510(k) Number K914177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date November 29, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

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