StitchKit

FDA UDI

Class II (US FDA UDI)

by Origami Surgical, LLC

Identity

Trade Name: StitchKit FDA UDI
Generic Name: Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name: StitchKit® RNY Suture and Needle Management Device FDA UDI
Model / Reference: SK-109 FDA UDI
Description: StitchKit® RNY Suture and Needle Management Device FDA UDI

Identifiers

Primary DI / UDI-DI: 00860004977377 FDA UDI
510(k) Number: K211792 FDA UDI
FDA Product Code: GCJ FDA UDI
NAY FDA UDI
GAM FDA UDI
GMDN Term: Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.4493 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial Barbed polyester suture, non-antimicrobial

StitchKit by Origami Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Barbed polyester suture, non-antimicrobial.

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V-Loc 90 — Covidien LP · Class II
V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II

Cleared under the same submission

K211792 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Origami Surgical, LLC

Sources (1)

FDA UDI 14dc546e-cf40-4f34-b93b-ab0c0688b65f 35 fields · synced May 30, 2026