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)

SOPROLIFE

K-Number: K092583 · 2010-01-13

ApplicantSopro
Decision Date2010-01-13
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOPROLIFE is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2010-01-13 under 510(k) number K092583. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPROLIFE?

SOPROLIFE is a medical device that received FDA 510(k) clearance on 2010-01-13. The listed applicant is Sopro. The 510(k) number is K092583.

When did SOPROLIFE receive FDA 510(k) clearance?

SOPROLIFE received FDA 510(k) clearance on 2010-01-13, under 510(k) number K092583.

Who is the listed applicant for SOPROLIFE?

The FDA 510(k) record lists Sopro as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOPROLIFE?

The FDA product code for SOPROLIFE is NBL.

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 Sopro 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.

K223470C50K121685SOPROCAREK103813SOPRO 281K092329SOPIX 2K082796SOPRO 184 CAMERAK080122SOPRO 670 ARTHROSCOPIC PUMP

View all 25 devices →

Related Devices (Code: NBL)

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.

K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.K242103TRIOS Ready Tip3Shape TRIOS A/SK221275Qraycam PROAIOBIO Co., Ltd.K231722SmarToothSmartooth Co., Ltd.K223470C50SoproK221249L1P-1F (TRIOS 5)3Shape TRIOS A/S

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.

↑