Cleared Traditional

K901425 - PYLORIC BALLOON DILATOR
(FDA 510(k) Clearance)

K901425 · Telemed Systems, Inc. · Gastroenterology & Urology

Jun 1990

Decision

87d

Days

Class 2

Risk

K901425 is an FDA 510(k) clearance for the PYLORIC BALLOON DILATOR, a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II — Special Controls, product code FAT), submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 21, 1990, 87 days after receiving the submission on March 26, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.

Submission Details

510(k) Number	K901425 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1990
Decision Date	June 21, 1990
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—