Cleared Traditional

REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (K930571) - FDA 510(k) Clearance

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

K930571 · Numed Technologies, Inc. · Obstetrics & Gynecology device
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Feb 1994
Decision
362d
Days
Class 2
Risk

K930571 is an FDA 510(k) clearance for the REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING. Classified as Coagulator, Culdoscopic (and Accessories) (product code HFI), Class II - Special Controls.

Submitted by Numed Technologies, Inc. (Independence, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K930571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date February 01, 1994
Days to Decision 362 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
202d slower than avg
Panel avg: 160d · This submission: 362d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFI Coagulator, Culdoscopic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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.