FDA 510(k)

Saans (F4-01-00-000-000)

K-Number: K251165 · 2026-01-06

ApplicantInnaccel Technologies Private Limited

Decision Date2026-01-06

Product CodeSGR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Saans (F4-01-00-000-000) is the device name listed in this FDA 510(k) record. The listed applicant is Innaccel Technologies Private Limited. It received FDA 510(k) clearance on 2026-01-06 under 510(k) 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. The listed applicant is Innaccel Technologies Private Limited. The 510(k) number is K251165.

When did Saans (F4-01-00-000-000) receive FDA 510(k) clearance?

Saans (F4-01-00-000-000) received FDA 510(k) clearance on 2026-01-06, under 510(k) number K251165.

Who is the listed applicant for Saans (F4-01-00-000-000)?

The FDA 510(k) record lists Innaccel Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.