ControlSeal Electrode (ELSB)— 510(k) K223605
Substantially EquivalentCoapt
FDA 510(k) clearance K223605 for ControlSeal Electrode (ELSB), Substantially Equivalent on 2022-12-30. Applicant: Coapt. Device class: 2.
Clearance details
- Applicant
- Coapt
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chicago, IL, US
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More clearances from Coapt
view allRecalls naming K223605
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 K223605.
Data sourced from openFDA. This site is unofficial and independent of the FDA.