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ORISE™ ProKnife

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
ORISE™ ProKnife FDA UDI
Generic Name
Endoscopic electrosurgical submucosal lift/resection instrument FDA UDI
Device Name
ORISE 2.0 mm Electrode - Kitted Device FDA UDI
Model / Reference
M00519390 FDA UDI
Description
ORISE 2.0 mm Electrode - Kitted Device FDA UDI

Identifiers

Primary DI / UDI-DI
08714729995593 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical 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

Yes

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: Endoscopic electrosurgical submucosal lift/resection instrument

ORISE™ ProKnife by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical submucosal lift/resection instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 9715b6f8-2195-4d84-90dd-6f871eb126c9 33 fields · synced Jun 6, 2026