Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPRINGFUSOR 10R

K-Number: K910007 · 1993-11-02

ApplicantGo Medical Industries Pty. , Ltd.
Decision Date1993-11-02
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPRINGFUSOR 10R is the device name listed in this FDA 510(k) record. The listed applicant is Go Medical Industries Pty. , Ltd.. It received FDA 510(k) clearance on 1993-11-02 under 510(k) number K910007. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRINGFUSOR 10R?

SPRINGFUSOR 10R is a medical device that received FDA 510(k) clearance on 1993-11-02. The listed applicant is Go Medical Industries Pty. , Ltd.. The 510(k) number is K910007.

When did SPRINGFUSOR 10R receive FDA 510(k) clearance?

SPRINGFUSOR 10R received FDA 510(k) clearance on 1993-11-02, under 510(k) number K910007.

Who is the listed applicant for SPRINGFUSOR 10R?

The FDA 510(k) record lists Go Medical Industries Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPRINGFUSOR 10R?

The FDA product code for SPRINGFUSOR 10R is FRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Go Medical Industries Pty. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011055THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADSK002803THE O'NEIL STERILE FIELD URINARY CATHETER KITK000263GO MEDICAL BALLOON INFUSION SYSTEMK900336V SETK895594SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLEK890400MODIFIED URINARY CATHETER INTRODUCER (UCI)

View all 11 devices →

Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑