Cleared Traditional

K942431 - LAPOROSCOPIC SCISSORS

K942431 is an FDA 510(k) clearance for LAPOROSCOPIC SCISSORS, manufactured by Enterprise Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 509-day FDA review.

K942431 · Enterprise Medical Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
509d
Days
Class 2
Risk

K942431 is an FDA 510(k) clearance for the LAPOROSCOPIC SCISSORS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Enterprise Medical Corp. (Greensboro, US). The FDA issued a Cleared decision on October 11, 1995 after a review of 509 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 Enterprise Medical Corp. devices

FDA 510(k) Submission Details - K942431

510(k) Number K942431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date October 11, 1995
Days to Decision 509 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
349d slower than avg
Panel avg: 160d · This submission: 509d
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 K942431.
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc. · Oct 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
KSEA MODEL 203200 20 UNIMAT
K953190 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265 · Cook Urological, Inc. · Sep 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · Olympus America, Inc. · Sep 1995