Cleared Traditional

K780349 - VAGINAL RETRACTOR (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K780349 · Edward Weck, Inc. · Obstetrics & Gynecology device
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Mar 1978
Decision
11d
Days
Class 1
Risk

K780349 is an FDA 510(k) clearance for the VAGINAL RETRACTOR. Classified as Retractor, Vaginal (product code HDL), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 14, 1978 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K780349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1978
Decision Date March 14, 1978
Days to Decision 11 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d faster than avg
Panel avg: 160d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HDL Retractor, Vaginal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.