CapsoCam Plus (SV-3) Capsule Endoscopy System— 510(k) K242643
Substantially EquivalentCapsoVision, Inc.
FDA 510(k) clearance K242643 for CapsoCam Plus (SV-3) Capsule Endoscopy System, Substantially Equivalent on 2024-12-04. Applicant: CapsoVision, Inc.. Device class: 2.
Clearance details
- Applicant
- CapsoVision, Inc.
- Product code
- Code NEZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saratoga, CA, US
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More clearances from CapsoVision, Inc.
view allAdverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.