Cleared Traditional

APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS (K040295) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040295 · Applied Medical Resources Corp. · Obstetrics & Gynecology device
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Mar 2004
Decision
32d
Days
Class 2
Risk

K040295 is an FDA 510(k) clearance for the APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 32 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Resources Corp. devices

Submission Details

510(k) Number K040295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date March 12, 2004
Days to Decision 32 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 160d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 98
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K040295.
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