StitchKit
K-Number: K221527 · 2023-02-14
ApplicantOrigami Surgical Inc .
Decision Date2023-02-14
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
StitchKit is a medical device manufactured by Origami Surgical Inc .. It received FDA 510(k) clearance on 2023-02-14 under approval number K221527. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StitchKit?
StitchKit is a medical device that received FDA 510(k) clearance on 2023-02-14. It is manufactured by Origami Surgical Inc .. The 510(k) number is K221527.
When was StitchKit approved by the FDA?
StitchKit received FDA 510(k) clearance on 2023-02-14, under approval number K221527.
What company makes StitchKit?
StitchKit is manufactured by Origami Surgical Inc ..
What is the FDA product code for StitchKit?
The FDA product code for StitchKit is GAM.
Other Devices by Origami Surgical Inc .
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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.