StitchKit COMBO
K-Number: K202950 · 2021-02-23
ApplicantOrigami Surgical
Decision Date2021-02-23
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
StitchKit COMBO is a medical device manufactured by Origami Surgical. It received FDA 510(k) clearance on 2021-02-23 under approval number K202950. 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 COMBO?
StitchKit COMBO is a medical device that received FDA 510(k) clearance on 2021-02-23. It is manufactured by Origami Surgical. The 510(k) number is K202950.
When was StitchKit COMBO approved by the FDA?
StitchKit COMBO received FDA 510(k) clearance on 2021-02-23, under approval number K202950.
What company makes StitchKit COMBO?
StitchKit COMBO is manufactured by Origami Surgical.
What is the FDA product code for StitchKit COMBO?
The FDA product code for StitchKit COMBO is GAM.
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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.