Cleared Traditional

K953574 - NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER

K953574 is an FDA 510(k) clearance for NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSA..., manufactured by American Hydro-Surgical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K953574 · American Hydro-Surgical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
60d
Days
Class 2
Risk

K953574 is an FDA 510(k) clearance for the NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by American Hydro-Surgical Instruments, Inc. (Delray Beach, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 American Hydro-Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K953574

510(k) Number K953574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date September 29, 1995
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 199
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K953574.
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