Cleared Traditional

K930756 - LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE

K930756 is an FDA 510(k) clearance for LAPAROSCOPIC IRRIGATION/ASPIRATION HAND..., manufactured by Endo Technic Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K930756 · Endo Technic Corp. · Obstetrics & Gynecology device
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Mar 1994
Decision
390d
Days
Class 2
Risk

K930756 is an FDA 510(k) clearance for the LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Endo Technic Corp. (Atlanta, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 390 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 Endo Technic Corp. devices

FDA 510(k) Submission Details - K930756

510(k) Number K930756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date March 09, 1994
Days to Decision 390 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
230d slower than avg
Panel avg: 160d · This submission: 390d
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 212
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K930756.
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
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ENDOPATH RELOADABLE LINEAR CUTTER
K930934 · Ethicon, Inc. · Mar 1994
RETRACTORS AND SCRAPER
K933008 · Baxter Healthcare Corp · Mar 1994
NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
K932634 · Marlo Surgical Technology · Feb 1994
PRIMUS INSULATED FORCEPS
K932832 · Marlo Surgical Technology · Feb 1994
ENTREE BLUNT TIP TROCAR AND ADAPTER
K932020 · Core Dynamics, Inc. · Jan 1994