Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
Bright Uro, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Irvine
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 3 Goddard
- Statement or summary
- Summary
- Product code
- EXQ
- Zip code
- 92618
- Applicant
- Bright Uro, Inc.
- Decision date
- 2025-03-24
- Decision code
- SESE
- Country code
- US
- Advisory committee
- GU
- Contact
- Dr. Roychowdhury Suranjan
- K number
- K243052
- State
- CA
- Date received
- 2024-09-27
- Review advisory committee
- GU
- Postal code
- 92618
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
- Harmonized identifiers (openFDA)
- Device name
- Cystometer, Electrical Recording
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1620
- Device class
- 2
- Registration number
- 3002806603, 3029753827, 3011790297, 3004967767, 3017448360, 3003631667, 3034397200, 1223851, 9611896, 3012174468, 3018383108, 3015447513, 3014929383, 9611102, 3034424132
- FEI number
- 3002806603, 3029753827, 3011790297, 3004967767, 3002808001, 3017448360, 3003631667, 3034397200, 3012174468, 3018383108, 3015447513, 3033428382, 3002957361, 3014929383, 3034424132