FDA.reportPublic FDA data

XAGA SURGICAL AB

Matched from indexed company URL: Xaga Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30386111813038611181XAGA SURGICAL AB1N2026-01-01Akerivagen 17 Eslov Skane SE SE 241 38

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3402511361154546K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)KNW2025-02-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNW12025-02-27

GUDID#

Forsvall biopsy gun - 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.

Xaga Surgical AB

2025-06-09

Forsvall biopsy needle - The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. TheForsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle issingle use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissuesamples. 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 stainlessmedical grade steel.

Xaga Surgical AB

2025-06-02

Forsvall biopsy gun - 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.

Xaga Surgical AB

2025-06-09

Forsvall biopsy needle - The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. 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.

Xaga Surgical AB

2025-06-02