Cleared Traditional

K925079 - LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)

K925079 is an FDA 510(k) clearance for LAPAROSCOPIC INST. (SCISSORS, 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 686-day FDA review.

K925079 · Endo Technic Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
686d
Days
Class 2
Risk

K925079 is an FDA 510(k) clearance for the LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Endo Technic Corp. (Northbrook, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 686 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Endo Technic Corp. devices

FDA 510(k) Submission Details - K925079

510(k) Number K925079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date August 24, 1994
Days to Decision 686 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
526d slower than avg
Panel avg: 160d · This submission: 686d
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 K925079.
IMAGYN LAPAROSCOPIC INSTRUMENTS
K944129 · Imagyn Medical, Inc. · Oct 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
SURGIMAT
K926259 · W.O.M. World of Medicine GmbH · Sep 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · Smith & Nephew Dyonics, Inc. · Aug 1994
VIDEO ENDOSCOPE-RIGID MODIFICATION
K921294 · Medical Dynamics, Inc. · Jul 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology · Jun 1994