StitchKit— 510(k) K191317

Substantially Equivalent

Origami Surgical

FDA 510(k) clearance K191317 for StitchKit, Substantially Equivalent on 2019-07-12. Applicant: Origami Surgical. Device class: 2.

Clearance details

Applicant: Origami Surgical
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2019-05-15
Decision date: 2019-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Origami Surgical

K202950 — StitchKit COMBO2021-02-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.