DACOMED CYSTOMETER
FDA 510(k) clearance K880391 · decided 1988-04-27
Clearance details
- K-number
- K880391
- Device name
- DACOMED CYSTOMETER
- Applicant
- Dacomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-29
- Decision date
- 1988-04-27
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EXQ
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dacomed Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| LIFE-TECH #1857 PRESSURE/POLOT MODULE (K812177) | Life-Tech Instruments, Inc. | 1981-09-09 |
| AQUA-GEL (K781032) | Murray, Salk, Inc. | 1978-12-15 |
Recalls involving this device
No recalls on record reference this clearance.