Cleared Traditional

K864865 - SPECULUM, VAGINAL, METAL FIBEROPTIC (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K864865 · Luxtec Corp. · Obstetrics & Gynecology device
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Jan 1987
Decision
29d
Days
Class 1
Risk

K864865 is an FDA 510(k) clearance for the SPECULUM, VAGINAL, METAL FIBEROPTIC. Classified as Speculum, Vaginal, Metal, Fiberoptic (product code HDG), Class I - General Controls.

Submitted by Luxtec Corp. (Sturbridge, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 29 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 Luxtec Corp. devices

Submission Details

510(k) Number K864865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1986
Decision Date January 09, 1987
Days to Decision 29 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
131d faster than avg
Panel avg: 160d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HDG Speculum, Vaginal, Metal, Fiberoptic
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.