Forsvall biopsy gun

FDA UDI

Class II (US FDA UDI)

by Xaga Surgical

Identity

Trade Name: Forsvall biopsy gun FDA UDI
Generic Name: Biopsy gun handpiece, mechanical FDA UDI
Device Name: The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsygun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel. FDA UDI
Model / Reference: Mech-00669 FDA UDI
Description: The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsygun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel. FDA UDI

Identifiers

Catalog Number: 24171-07-02 FDA UDI
Primary DI / UDI-DI: 07309861000079 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Biopsy gun handpiece, mechanical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Biopsy gun handpiece, mechanical

Forsvall biopsy gun by Xaga Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Xaga Surgical

Sources (1)

FDA UDI 678d1d41-80d6-40ae-9dda-ad3f14f0a0a5 34 fields · synced Jun 8, 2026