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StitchKit

FDA UDI

Class II (US FDA UDI)

by Origami Surgical, LLC

Identity

Trade Name
StitchKit FDA UDI
Generic Name
Polytetrafluoroethylene suture FDA UDI
Device Name
StitchKit ePTFE Suture Delivery Canister FDA UDI
Model / Reference
SK-002 FDA UDI
Description
StitchKit ePTFE Suture Delivery Canister FDA UDI

Identifiers

Primary DI / UDI-DI
00860088000206 FDA UDI
510(k) Number
K123811 FDA UDI
FDA Product Code
NAY FDA UDI
GCJ FDA UDI
NBY FDA UDI
GMDN Term
Polytetrafluoroethylene suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.5035 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polytetrafluoroethylene suture

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

Similar devices

Also classified as Polytetrafluoroethylene suture.

Cleared under the same submission

K123811 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Origami Surgical, LLC

Sources (1)

  • FDA UDI 4e2efc2a-6c51-4629-8754-39115cca344f 35 fields · synced May 30, 2026