Product code EXR— Gastroenterology, Urology

FDA has cleared 9 devices under product code EXR between 1977 and 1994, 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.

• 19941 clearance
• 19931 clearance
• 19911 clearance
• 19901 clearance
• 19871 clearance
• 19774 clearances

• Brother Scientific Products, Inc.2 clearances
• Will Ross Co.1 clearance
• Unoplast A/S1 clearance
• Puritas Health Care, Inc.1 clearance
• Key Medical Services, Inc.1 clearance
• Kendall Healthcare Products Co. Div.Of Tyco Health1 clearance
• Fraass Survival Systems, Inc.1 clearance
• C.R. Bard, Inc.1 clearance

• K934142 — URINARY DRAINAGE BAGKey Medical Services, Inc.·1994-05-17
• K935578 — URINE METERPuritas Health Care, Inc.·1993-12-17
• K911258 — KENDALL PEDIATRIC URINE METERKendall Healthcare Products Co. Div.Of Tyco Health·1991-04-25
• K896732 — UNOMETER 500Unoplast A/S·1990-11-02
• K870240 — COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.·1987-02-20
• K771561 — DOVER URINE METERWill Ross Co.·1977-09-07
• K770423 — URINE TESTER, MODEL NO. 707Brother Scientific Products, Inc.·1977-06-03
• K770939 — URINE TESTER, MODEL 701Brother Scientific Products, Inc.·1977-06-03
• K761083 — BARD URINE METER W/ BAGC.R. Bard, Inc.·1977-01-26