Dacomed Cystometer
FDA 510(k) K880391 · Dacomed Corp.
510(k) numberK880391
Submission
- Device name
- Dacomed Cystometer
- Applicant
- Dacomed Corp.
Minneapolis, MN, US - Received
- January 29, 1988
- Decision date
- April 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXQ – Cystometer, Electrical Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…EXQ · Traditional | Bright Uro, Inc. | 04/16/2026SE |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…EXQ · Traditional | Bright Uro, Inc. | 03/24/2025SE |
| K931282 | Volume TransducerEXQ · Traditional | Life-Tech Intl., Inc. | 09/17/1993SE |
| K931574 | Advance Model Uds-AdvEXQ · Traditional | Laborie Medical Technologies, Ltd. | 08/05/1993SE |
| K920574 | Camsys 6300EXQ · Traditional | F.M. Wiest USA, Inc. | 02/17/1993SE |
| K812177 | Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional | Life-Tech Instruments, Inc. | 09/09/1981SE |
| K781032 | Aqua-GelEXQ · Traditional | Murray, Salk, Inc. | 12/15/1978SE |
More from Murray, Salk, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953640 | Duna II Penile ProsthesisFAE · Traditional | 10/27/1995SE |
| K941781 | Rigiscan Plus Rigidity Assessment SystemLIL · Traditional | 08/25/1994SE |
| K920409 | Dacomed Battery Operated Vacuum Erection DeviceLKY · Traditional | 05/11/1992SE |
| K920420 | Dura II Penile ProsthesisFAE · Traditional | 04/16/1992SE |
| K912344 | Modified Duraphase(Tm) Implanted Penile ProsthesisFAE · Traditional | 10/11/1991SE |
| K900774 | Dacomed Negative Pressure Erection DeviceLKY · Traditional | 05/04/1990SE |
| K885323 | Dacomed External Male Continence DeviceFHA · Traditional | 02/08/1989SE |
| K871653 | Duraphase Penile ProsthesisFAE · Traditional | 09/18/1987SE |
| K870320 | Dacomed Penile Prosthesis SizerJLW · Traditional | 03/17/1987SE |
| K854118 | Dacomed Corp. Eska-Herrman Voice ProsthesisEWL · Traditional | 03/17/1986SE |
Questions and answers
When was Dacomed Cystometer cleared by the FDA?
Dacomed Cystometer (K880391) received a 510(k) decision of Substantially Equivalent on April 27, 1988, 89 days after the submission was received.
What is the product code of K880391?
The FDA product code is EXQ – Cystometer, Electrical Recording, a Class II (moderate risk) device regulated under 21 CFR 876.1620.