510(k) K253537
- Device
- 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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)
- Applicant
- Bright Uro, Inc.
- 510(k) number
- K253537
- Product code
- EXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-16
- Date received
- 2025-11-13
- Regulation
- 876.1620
- Classification name
- Cystometer, Electrical Recording
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Suranjan Roychowdhury
- Address
- 3 Goddard Irvine CA US 92618 92618
FDA Registration Numbers#
- 1223851
- 3034424132
- 3029753827
- 3017448360
- 9611896
- 3018383108
- 3003631667
- 9611102
- 3012174468
- 3034397200
- 3014929383
- 3011790297
- 3002806603
- 3004967767
- 3015447513
Source Documents#
Other 510(k) Records For Product Code EXQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243052 | 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. | 2025-03-24 |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | 1981-09-09 |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | 1978-12-15 |