AQUA-GEL
FDA 510(k) clearance K781032 · decided 1978-12-15
Clearance details
- K-number
- K781032
- Device name
- AQUA-GEL
- Applicant
- Murray, Salk, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-19
- Decision date
- 1978-12-15
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- EXQ
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) (K253537) | Bright Uro, Inc. | 2026-04-16 |
| 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)) (K243052) | Bright Uro, Inc. | 2025-03-24 |
| VOLUME TRANSDUCER (K931282) | Life-Tech Intl., Inc. | 1993-09-17 |
| ADVANCE MODEL UDS-ADV (K931574) | Laborie Medical Technologies, Ltd. | 1993-08-05 |
| CAMSYS 6300 (K920574) | F.M. Wiest USA, Inc. | 1993-02-17 |
| DACOMED CYSTOMETER (K880391) | Dacomed Corp. | 1988-04-27 |
| LIFE-TECH #1857 PRESSURE/POLOT MODULE (K812177) | Life-Tech Instruments, Inc. | 1981-09-09 |
Recalls involving this device
No recalls on record reference this clearance.