Product code FAT— Gastroenterology, Urology

FDA has cleared 8 devices under product code FAT between 1978 and 2014, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20141 clearance
• 19991 clearance
• 19981 clearance
• 19961 clearance
• 19901 clearance
• 19851 clearance
• 19841 clearance
• 19781 clearance

• Telemed Systems, Inc.1 clearance
• Teleflexmedical, Inc.1 clearance
• Stryker Endoscopy1 clearance
• Mill-Rose Laboratory1 clearance
• Medovations, Inc.1 clearance
• Gaymar Industries, Inc.1 clearance
• Gabriel Medical, Inc.1 clearance
• Dacomed Corp.1 clearance

• K133439 — PILLING ESOPHAGEAL BOUGIESTeleflexmedical, Inc.·2014-06-16
• K983220 — STRYKER INFRAVISION ESOPHAGEAL KITStryker Endoscopy·1999-06-04
• K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.·1998-02-02
• K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.·1996-06-27
• K901425 — PYLORIC BALLOON DILATORTelemed Systems, Inc.·1990-06-21
• K843186 — ESKA MULTISTAGE ESOPHAGEAL BOUGIEDacomed Corp.·1985-01-18
• K842679 — ESOPHAGEAL DILATOR SETMill-Rose Laboratory·1984-10-02
• K780471 — GASTRIC LAVAGE KITGaymar Industries, Inc.·1978-06-02