Cleared Traditional

K022748 - REPROCSSED USED DISPOSABLE ENDOSCOPIC S...

K022748 is an FDA 510(k) clearance for REPROCSSED USED DISPOSABLE ENDOSCOPIC S..., manufactured by Medical Device Services. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K022748 · Medical Device Services · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
51d
Days
Class 2
Risk

K022748 is an FDA 510(k) clearance for the REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 51 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 Medical Device Services devices

FDA 510(k) Submission Details - K022748

510(k) Number K022748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date October 09, 2002
Days to Decision 51 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
109d faster than avg
Panel avg: 160d · This submission: 51d
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 K022748.
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · Richard Wolf Medical Instruments Corp. · Jul 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · Applied Medical Resources Corp. · Mar 2004
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · CooperSurgical, Inc. · Apr 2003
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp. · Jan 2001
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · Xomed, Inc. · Jun 2000