Cleared Traditional

K936071 - SMITH & NEPHEW DYONICS INC. ELECTRONIC ...

K936071 is an FDA 510(k) clearance for SMITH & NEPHEW DYONICS INC. ELECTRONIC ..., manufactured by Smith & Nephew Dyonics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K936071 · Smith & Nephew Dyonics, Inc. · Obstetrics & Gynecology device
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Aug 1994
Decision
242d
Days
Class 2
Risk

K936071 is an FDA 510(k) clearance for the SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Smith & Nephew Dyonics, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on August 19, 1994 after a review of 242 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

View all Smith & Nephew Dyonics, Inc. devices

FDA 510(k) Submission Details - K936071

510(k) Number K936071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date August 19, 1994
Days to Decision 242 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
82d slower than avg
Panel avg: 160d · This submission: 242d
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 176
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