Cleared Traditional

K911353 - EMC MODEL NO. STATOME 900

K911353 is an FDA 510(k) clearance for EMC MODEL NO. STATOME 900, manufactured by Emc Industries. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K911353 · Emc Industries · General & Plastic Surgery device
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Jun 1991
Decision
89d
Days
Class 2
Risk

K911353 is an FDA 510(k) clearance for the EMC MODEL NO. STATOME 900. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Emc Industries (Los Altos, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 Emc Industries devices

FDA 510(k) Submission Details - K911353

510(k) Number K911353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1991
Decision Date June 24, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAM Device Classification - Class 2, Special Controls

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HAM Apparatus, Electrosurgical

All 14
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K911353.
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