Product code FFG— Gastroenterology, Urology
1URO-LOG HOME DIAGNOSTIC PACK
- Classification name
- Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class 2
- Regulation
- 21 CFR 876.1800
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code FFG
FDA has cleared devices under product code FFG between 1977 and 1989, filed by 15 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.
Clearances per year
- 1989
- 1985
- 1984
- 1982
- 1981
- 1979
- 1978
- 1977
Top applicants under product code FFG
Recent clearances under product code FFG
- K893827 — PEAK FLOW RATE METER
- K883274 — SURGITEK (R) UROFLOW SYSTEM
- K850169 — ERIS URO-DIAGNOSTIC SYSTEM
- K844338 — 1URO-LOG HOME DIAGNOSTIC PACK
- K843441 — URINARY DRAINAGE CONTAINER 2012-WITH
- K843442 — URINARY DRAINAGE CONTAINER 2013 WITH
- K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM
- K843224 — UROPUMP MODEL 1711
- K833043 — UROMETER
- K813641 — VITAL METRICS URINE MONITORING SYSTEM
- K813082 — UREOFIX 500 URINE MEASURING SYSTEM
- K811925 — UROFLOWMETER
- K790894 — URITRON URINE METER
- K790365 — FLUID MEASUREMENT STAND
- K790663 — MODEL 1750 STANDING URINAL
- K781597 — PM 2000 AUTOMATIC PATIENT CHAIR
- K771655 — CURITY PEAKOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.