CapsoCam Plus (SV-3)— 510(k) K183192
Substantially EquivalentCapsoVision, Inc.
FDA 510(k) clearance K183192 for CapsoCam Plus (SV-3), Substantially Equivalent on 2019-04-19. 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
- Special
- 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 →
Recalls naming K183192
K-number listed on FDA's recall record- Z-1827-2020 — CapsoCAM Plus, UDI: 00867770000209
- Z-2073-2020 — CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183192.
Data sourced from openFDA. This site is unofficial and independent of the FDA.