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AED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscope Working Element

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
AED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscope Working Element FDA UDI
Generic Name
Resectoscope FDA UDI
Device Name
An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. FDA UDI
Model / Reference
HW5410-BP FDA UDI
Description
An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. FDA UDI

Identifiers

Catalog Number
HW5410-BP FDA UDI
Primary DI / UDI-DI
00848657074926 FDA UDI
510(k) Number
K141515 FDA UDI
FDA Product Code
HIH FDA UDI
GMDN Term
Resectoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Resectoscope

AED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscope Working Element by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Resectoscope.

Cleared under the same submission

K141515 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Advanced Endoscopy Devices, Inc.

Sources (1)

  • FDA UDI 6f9c85c5-057e-4e8e-b2c1-aa298e0d7eff 36 fields · synced May 29, 2026