Cleared Traditional

K922248 - MALLAWANY ATRAUMATIC TISSUE FORCEPS

K922248 is an FDA 510(k) clearance for MALLAWANY ATRAUMATIC TISSUE FORCEPS, manufactured by Numed Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 645-day FDA review.

K922248 · Numed Technologies, Inc. · Obstetrics & Gynecology device
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Feb 1994
Decision
645d
Days
Class 2
Risk

K922248 is an FDA 510(k) clearance for the MALLAWANY ATRAUMATIC TISSUE FORCEPS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Numed Technologies, Inc. (Independence, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 645 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 Numed Technologies, Inc. devices

FDA 510(k) Submission Details - K922248

510(k) Number K922248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date February 17, 1994
Days to Decision 645 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
485d slower than avg
Panel avg: 160d · This submission: 645d
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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K922248.
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