CapsoCam Plus (SV-3)
K-Number: K183192 · 2019-04-19
ApplicantCapsoVision, Inc.
Decision Date2019-04-19
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CapsoCam Plus (SV-3) is a medical device manufactured by CapsoVision, Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval number K183192. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CapsoCam Plus (SV-3)?
CapsoCam Plus (SV-3) is a medical device that received FDA 510(k) clearance on 2019-04-19. It is manufactured by CapsoVision, Inc.. The 510(k) number is K183192.
When was CapsoCam Plus (SV-3) approved by the FDA?
CapsoCam Plus (SV-3) received FDA 510(k) clearance on 2019-04-19, under approval number K183192.
What company makes CapsoCam Plus (SV-3)?
CapsoCam Plus (SV-3) is manufactured by CapsoVision, Inc..
What is the FDA product code for CapsoCam Plus (SV-3)?
The FDA product code for CapsoCam Plus (SV-3) is NEZ.
Other Devices by CapsoVision, Inc.
Related Devices (Code: NEZ)
K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc.
K151635CapsoCam (SV-1)CapsoVision, Inc.
K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd.
K170839RAPID WebGiven Imaging , Ltd.
K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc.
K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.