Elite

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Elite FDA UDI
Generic Name: Rigid endoscope working guide FDA UDI
Device Name: Repair-Exchange, Iglesias Bipolar PK Working Element FDA UDI
Model / Reference: REXEIWE-BRPK FDA UDI
Description: Repair-Exchange, Iglesias Bipolar PK Working Element FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925008243 FDA UDI
510(k) Number: K021166 FDA UDI
FDA Product Code: FBO FDA UDI
GMDN Term: Rigid endoscope working guide FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope working guide

Elite by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rigid endoscope working guide.

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Urethrotome sheath only, 21Ch. — mahe medical gmbh · Class II
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Olympus — Olympus Winter & Ibe GmbH · Class II
Resectoscopy working unit, passive, closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II

Cleared under the same submission

K021166 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 8f846894-d6f3-42c9-b02e-88e4c1f0c43a 34 fields · synced May 30, 2026