GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER— 510(k) K132383
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K132383 for GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER, Substantially Equivalent on 2014-02-04. Applicant: Gyrus Acmi, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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More clearances from Gyrus Acmi, Inc.
view all- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
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- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
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Adverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
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 K132383
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132383.
Data sourced from openFDA. This site is unofficial and independent of the FDA.