FAT · Class II · 21 CFR 876.5365

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

Leading manufacturers include Teleflexmedical, Inc., Gaymar Industries, Inc. and Mill-Rose Laboratory.

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 Feb 02, 1998
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
K972119
Medovations, Inc.
Gastroenterology & Urology · 242d
Cleared Jun 27, 1996
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K960173
Gabriel Medical, Inc.
Gastroenterology & Urology · 163d
Cleared Jun 21, 1990
PYLORIC BALLOON DILATOR
K901425
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 18, 1985
ESKA MULTISTAGE ESOPHAGEAL BOUGIE
K843186
Dacomed Corp.
Gastroenterology & Urology · 158d
Cleared Oct 02, 1984
ESOPHAGEAL DILATOR SET
K842679
Mill-Rose Laboratory
Gastroenterology & Urology · 84d
Cleared Jun 02, 1978
GASTRIC LAVAGE KIT
K780471
Gaymar Industries, Inc.
Gastroenterology & Urology · 70d

About Product Code FAT - Regulatory Context