Cleared Traditional

ESKA MULTISTAGE ESOPHAGEAL BOUGIE

K843186 · Dacomed Corp. · Gastroenterology & Urology
Jan 1985
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K843186 is an FDA 510(k) clearance for the ESKA MULTISTAGE ESOPHAGEAL BOUGIE, a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II — Special Controls, product code FAT), submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on January 18, 1985, 158 days after receiving the submission on August 13, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.

Submission Details

510(k) Number K843186 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1984
Decision Date January 18, 1985
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5365

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