Cleared Traditional

ENDOSCANN (K831212) - FDA 510(k) Clearance

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

K831212 · Axcan Scientific Corp. · Obstetrics & Gynecology device
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Jun 1984
Decision
428d
Days
Class 2
Risk

K831212 is an FDA 510(k) clearance for the ENDOSCANN. Classified as Aspirator, Endometrial (product code HFF), Class II - Special Controls.

Submitted by Axcan Scientific Corp. (Walker, US). The FDA issued a Cleared decision on June 15, 1984 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1060 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Axcan Scientific Corp. devices

Submission Details

510(k) Number K831212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1983
Decision Date June 15, 1984
Days to Decision 428 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
268d slower than avg
Panel avg: 160d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFF Aspirator, Endometrial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1060
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.