Cleared Traditional

K982149 - SMITH & NEPHEW DYONICS MICROLAPAROSCOPE (FDA 510(k) Clearance)

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

K982149 · Smith & Nephew, Inc. · Obstetrics & Gynecology device
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Sep 1998
Decision
84d
Days
Class 2
Risk

K982149 is an FDA 510(k) clearance for the SMITH & NEPHEW DYONICS MICROLAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on September 10, 1998 after a review of 84 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K982149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1998
Decision Date September 10, 1998
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.