ECOGEL 100 ULTRASOUND GEL— 510(k) K961757
Substantially EquivalentEco-Med Pharmaceuticals, Inc.
FDA 510(k) clearance K961757 for ECOGEL 100 ULTRASOUND GEL, Substantially Equivalent on 1996-07-25. Applicant: Eco-Med Pharmaceuticals, Inc.. Device class: 2.
Clearance details
- Applicant
- Eco-Med Pharmaceuticals, Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, Ontario, CA
Recent devices under product code ITX
view allMore clearances from Eco-Med Pharmaceuticals, Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K961757
K-number listed on FDA's recall record- Z-2480-2021 — EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
- Z-0090-2022 — EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961757.
Data sourced from openFDA. This site is unofficial and independent of the FDA.