FAT · Class II · 21 CFR 876.5365

FDA Product Code FAT: Bougie, Esophageal, And Gastrointestinal, Gastro-urology

Leading manufacturers include Teleflexmedical, Inc., Mill-Rose Laboratory and Stryker Endoscopy.

8
Total
8
Cleared
160d
Avg days
1978
Since

FDA 510(k) Cleared Bougie, Esophageal, And Gastrointestinal, Gastro-urology Devices (Product Code FAT)

8 devices
1–8 of 8
Cleared Jun 16, 2014
PILLING ESOPHAGEAL BOUGIES
K133439
Teleflexmedical, Inc.
Gastroenterology & Urology · 216d
Cleared Jun 04, 1999
STRYKER INFRAVISION ESOPHAGEAL KIT
K983220
Stryker Endoscopy
Gastroenterology & Urology · 263d
Cleared Oct 02, 1984
ESOPHAGEAL DILATOR SET
K842679
Mill-Rose Laboratory
Gastroenterology & Urology · 84d

About Product Code FAT - Regulatory Context