ECOGEL 200 ULTRASOUND GEL
FDA 510(k) clearance K955246 · decided 1996-02-21
Clearance details
- K-number
- K955246
- Device name
- ECOGEL 200 ULTRASOUND GEL
- Applicant
- Eco-Med Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-15
- Decision date
- 1996-02-21
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 recall (Z-0194-2022) | Lumenis, Inc. | 2021-11-04 |
| LiquaSonic Ultrasound Gel 250mL, Model No. 001205 recall (Z-2391-2021) | Athena Medical Products Inc | 2021-09-09 |
| LiquaSonic Ultrasound Gel 5L, Model No. 001222 recall (Z-2392-2021) | Athena Medical Products Inc | 2021-09-09 |