PRISMAFLO II— 510(k) K082758
Substantially EquivalentStihler Electronic GmbH
FDA 510(k) clearance K082758 for PRISMAFLO II, Substantially Equivalent on 2008-12-19. Applicant: Stihler Electronic GmbH. Device class: 2.
Clearance details
- Applicant
- Stihler Electronic GmbH
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sound Beach, NY, US
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More clearances from Stihler Electronic GmbH
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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 K082758
K-number listed on FDA's recall record- Z-0759-2019 — Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
- Z-0760-2019 — Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
- Z-0761-2019 — Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082758.
Data sourced from openFDA. This site is unofficial and independent of the FDA.