KILTEX PROBE COVER— 510(k) K961029
Substantially EquivalentKiltex Corp.
FDA 510(k) clearance K961029 for KILTEX PROBE COVER, Substantially Equivalent on 1996-07-25. Applicant: Kiltex Corp.. Device class: 2.
Clearance details
- Applicant
- Kiltex Corp.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Akron, OH, US
Recent devices under product code IYO
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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 K961029
K-number listed on FDA's recall record- Z-2332-2018 — ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
- Z-2333-2018 — ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961029.
Data sourced from openFDA. This site is unofficial and independent of the FDA.