Single-use Extraction Baskets

FDA UDI

Class II (US FDA UDI)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name: Single-use Extraction Baskets FDA UDI
Generic Name: Urinary stone retrieval basket, single-use FDA UDI
Device Name: The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system. FDA UDI
Model / Reference: EBF-1511SG FDA UDI
Description: The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system. FDA UDI

Identifiers

Primary DI / UDI-DI: 06971381252750 FDA UDI
510(k) Number: K240192 FDA UDI
FDA Product Code: LQR FDA UDI
GMDN Term: Urinary stone retrieval basket, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Category: Urinary stone retrieval basket, single-use

Single-use Extraction Baskets by Scivita Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K240192 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: Scivita Medical Technology Co., Ltd.

Sources (1)

FDA UDI 70b23771-1298-4ade-b113-5e671b7e927c 35 fields · synced May 30, 2026