FDA.reportPublic FDA data

URO-1, INC.

Matched from indexed company URL: Uro-1, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30272693403027269340URO-1, INC.1N2026-01-013703 Alliance Drive Suite A Greensboro NC US 27407

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860014338625SUREcore Plus Biopsy Instrument - "A needle biopsy system consisting of a needle and an instrument (""gun"") to facilitate biopsy of soft tissue. The needle is advanced to the target tissue under image guidance and then the instrument fires the needle in order to obtain a core of tissue that then is prepared for analysis by a pathologist."3369305464info@uro1medical.com
00860014338663SUREcore Plus Biopsy Instrument - "The SUREcore Plus Biopsy Instrument, with a length of 25 cm, facilitates biopsy of soft tissue. It consists of a biopsy needle and an instrument (""gun""). The needle is advanced under imaging to the target tissue and the instrument fires the needle into the tissue to obtain a core of tissue. The tissue core is than sent to pathology for analysis. It is a single-use device."336 930 5464info@uro1medical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3166791276025215K230646SUREcore Prime Biopsy InstrumentKNW2023-11-29
3166791209016991K220611SUREcore Plus Biopsy InstrumentKNW2022-12-02
3166791169012067K201650VMCore Biopsy NeedleKNW2021-01-15
3166792054127421K180214Repris Bladder Injection SystemFBK2018-05-03
3166791596426370

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNW32023-11-29
FBK12018-05-03

PMN#

GUDID#