HS Fiber
K-Number: K252201 · 2025-08-13
ApplicantRiverpoint Medical
Decision Date2025-08-13
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HS Fiber is a medical device manufactured by Riverpoint Medical. It received FDA 510(k) clearance on 2025-08-13 under approval number K252201. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HS Fiber?
HS Fiber is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Riverpoint Medical. The 510(k) number is K252201.
When was HS Fiber approved by the FDA?
HS Fiber received FDA 510(k) clearance on 2025-08-13, under approval number K252201.
What company makes HS Fiber?
HS Fiber is manufactured by Riverpoint Medical.
What is the FDA product code for HS Fiber?
The FDA product code for HS Fiber is GAT.
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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.