Aqua-Gel
FDA 510(k) K781032 · Murray, Salk, Inc.
510(k) numberK781032
Submission
- Device name
- Aqua-Gel
- Applicant
- Murray, Salk, Inc.
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- December 15, 1978
- 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 |
| K880391 | Dacomed CystometerEXQ · Traditional | Dacomed Corp. | 04/27/1988SE |
| K812177 | Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional | Life-Tech Instruments, Inc. | 09/09/1981SE |
Questions and answers
When was Aqua-Gel cleared by the FDA?
Aqua-Gel (K781032) received a 510(k) decision of Substantially Equivalent on December 15, 1978, 179 days after the submission was received.
What is the product code of K781032?
The FDA product code is EXQ – Cystometer, Electrical Recording, a Class II (moderate risk) device regulated under 21 CFR 876.1620.