Cleared Traditional

K912093 - DISPOSABLE ASPIRATION IRRIGATION SYSTEM

K912093 is an FDA 510(k) clearance for DISPOSABLE ASPIRATION IRRIGATION SYSTEM, manufactured by Applied Urology, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K912093 · Applied Urology, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
346d
Days
Class 2
Risk

K912093 is an FDA 510(k) clearance for the DISPOSABLE ASPIRATION IRRIGATION SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on April 24, 1992 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Urology, Inc. devices

FDA 510(k) Submission Details - K912093

510(k) Number K912093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date April 24, 1992
Days to Decision 346 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 160d · This submission: 346d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K912093.
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · United States Surgical, A Division of Tyco Healthc · Sep 1992
WECK TROCAR
K915378 · Edward Weck, Inc. · Jun 1992
TROCAR SHEATH ANCHOR
K915116 · Origin Medsystems, Inc. · Jun 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · Cook Ob/Gyn · Feb 1992
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K914968 · Ethicon, Inc. · Feb 1992
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
K912398 · Ethicon, Inc. · Dec 1991