FDA 510(k) clearance · back to tracker

Emprint Ablation System with Thermosphere Technology

Covidien, LLC cleared K200796 on 2020-08-26, decision: substantially equivalent

K-number

K200796

Sponsor

Covidien, LLC

Device

Emprint Ablation System with Thermosphere Technology

Class

Class II

Decision

Substantially Equivalent

Decision date

2020-08-26

Product code

NEY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K200796on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.