StitchKit

Suture, Absorbable, Synthetic, Polyglycolic Acid

Origami Surgical Inc .

The following data is part of a premarket notification filed by Origami Surgical Inc . with the FDA for Stitchkit.

Pre-market Notification Details

Device IDK211792
510k NumberK211792
Device Name:StitchKit
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant Origami Surgical Inc . 42 Main St. Madison,  NJ  07940
ContactJohn Gillespie
CorrespondentJohn Gillespie
Origami Surgical Inc . 42 Main St. Madison,  NJ  07940
Product CodeGAM  
Subsequent Product CodeGAT
Subsequent Product CodeGCJ
Subsequent Product CodeNAY
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-10
Decision Date2021-07-16

Trademark Results [StitchKit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STITCHKIT
STITCHKIT
85662513 4286173 Live/Registered
Origami Surgical, LLC
2012-06-27

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