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Creo Medical

FDA UDI

Class II (US FDA UDI)

by Creo Medical, Ltd.

Identity

Trade Name
Creo Medical FDA UDI
Generic Name
Endoscopic electrosurgical/microwave submucosal lift/resection instrument FDA UDI
Device Name
A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device. FDA UDI
Model / Reference
7-RS2-001 FDA UDI
Description
A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device. FDA UDI

Identifiers

Catalog Number
7-RS2-001 FDA UDI
Primary DI / UDI-DI
05060359560025 FDA UDI
510(k) Number
K171983 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical/microwave submucosal lift/resection instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

Dimensions & Sizes

Size
Outer Diameter — 3.7 Millimeter FDA UDI
Catheter Length — 2.3 Meter FDA UDI

Category: Endoscopic electrosurgical/microwave submucosal lift/resection instrument

Creo Medical by Creo Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical/microwave submucosal lift/resection instrument.

Cleared under the same submission

K171983 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Creo Medical, Ltd.

Sources (1)

  • FDA UDI 17a07c0e-4ef9-4eec-ac46-a1cfb6ed6912 38 fields · synced Jun 6, 2026