← Back to catalogue

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® URO Suture and Needle Management Device FDA UDI
Model / Reference
SK-110 FDA UDI
Description
StitchKit® URO Suture and Needle Management Device FDA UDI

Identifiers

Primary DI / UDI-DI
00860004977384 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

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: Polyester suture, bioabsorbable, multifilament, non-antimicrobialPolyester suture, bioabsorbable, monofilament, non-antimicrobial

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

Similar devices

Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.

Cleared under the same submission

K211792 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Origami Surgical, LLC

Sources (1)

  • FDA UDI 598e3313-88a3-49f3-bad9-241421f39a4c 35 fields · synced May 30, 2026