Saans (F4-01-00-000-000)
K-Number: K251165 · 2026-01-06
Decision Date2026-01-06
Product CodeSGR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Saans (F4-01-00-000-000) is a medical device manufactured by Innaccel Technologies Private Limited. It received FDA 510(k) clearance on 2026-01-06 under approval number K251165. The device is classified under product code SGR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Saans (F4-01-00-000-000)?
Saans (F4-01-00-000-000) is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Innaccel Technologies Private Limited. The 510(k) number is K251165.
When was Saans (F4-01-00-000-000) approved by the FDA?
Saans (F4-01-00-000-000) received FDA 510(k) clearance on 2026-01-06, under approval number K251165.
What company makes Saans (F4-01-00-000-000)?
Saans (F4-01-00-000-000) is manufactured by Innaccel Technologies Private Limited.
What is the FDA product code for Saans (F4-01-00-000-000)?
The FDA product code for Saans (F4-01-00-000-000) is SGR.
Related Devices (Code: SGR)
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.