Cleared Traditional

K951119 - NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM

K951119 is an FDA 510(k) clearance for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM, manufactured by American Hydro-Surgical Instruments, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K951119 · American Hydro-Surgical Instruments, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
95d
Days
Class 2
Risk

K951119 is an FDA 510(k) clearance for the NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by American Hydro-Surgical Instruments, Inc. (Delray Beach, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 American Hydro-Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K951119

510(k) Number K951119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date June 13, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 53
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