Cleared Traditional

K040295 - APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS

K040295 is an FDA 510(k) clearance for APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS, manufactured by Applied Medical Resources Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K040295 · Applied Medical Resources Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K040295

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 175
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K040295.
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404 · Intuitive Surgical, Inc. · Apr 2005
MILTEX LAPAROSCOPIC INSTRUMENTS
K043013 · Miltex, Inc. · Mar 2005
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · Richard Wolf Medical Instruments Corp. · Jul 2004
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · CooperSurgical, Inc. · Apr 2003
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · A & A Medical, Inc. · May 2001
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.