MEDISYSTEMS BUTTONHOLE NEEDLE SETS— 510(k) K990803
Substantially EquivalentMedisystems Corp.
FDA 510(k) clearance K990803 for MEDISYSTEMS BUTTONHOLE NEEDLE SETS, Substantially Equivalent on 2000-01-06. Applicant: Medisystems Corp.. Device class: 2.
Clearance details
- Applicant
- Medisystems Corp.
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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More clearances from Medisystems Corp.
view allAdverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
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 K990803
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 K990803.
Data sourced from openFDA. This site is unofficial and independent of the FDA.