Cleared Traditional

K925114 - LAPAROSCOPIC INSTRUMENTS

K925114 is an FDA 510(k) clearance for LAPAROSCOPIC INSTRUMENTS, manufactured by Endo Technic Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFI cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K925114 · Endo Technic Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
507d
Days
Class 2
Risk

K925114 is an FDA 510(k) clearance for the LAPAROSCOPIC INSTRUMENTS. Classified as Coagulator, Culdoscopic (and Accessories) (product code HFI), Class II - Special Controls.

Submitted by Endo Technic Corp. (Northbrook, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - 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 - K925114

510(k) Number K925114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date February 28, 1994
Days to Decision 507 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
347d slower than avg
Panel avg: 160d · This submission: 507d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFI Device Classification - Class 2, Special Controls

Product Code HFI Coagulator, Culdoscopic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 - HFI Coagulator, Culdoscopic (and Accessories)

Devices cleared under the same product code (HFI) and FDA review panel - the closest regulatory comparables to K925114.
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925957 · Zinnanti Surgical Instruments, Inc. · Jun 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925960 · Zinnanti Surgical Instruments, Inc. · Jun 1994
COOK LAPAROSCOPIC MINI RETRACTOR SET
K936026 · Cook Urological, Inc. · Mar 1994
CANON 60 DEGREE FUNDUS CAMERA CF-60S
K844053 · Canon USA, Inc. · Dec 1984