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)

OPRAFLEX

K-Number: K812501 · 1981-10-02

ApplicantSelomas, Inc.
Decision Date1981-10-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

OPRAFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Selomas, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812501. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPRAFLEX?

OPRAFLEX is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Selomas, Inc.. The 510(k) number is K812501.

When did OPRAFLEX receive FDA 510(k) clearance?

OPRAFLEX received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812501.

Who is the listed applicant for OPRAFLEX?

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

What is the FDA product code for OPRAFLEX?

The FDA product code for OPRAFLEX is FRO. This falls under the Anesthesiology category.

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 Selomas, Inc. 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.

K861215GAUZE SPONGES USP TYPE VIIK821258SELOPORK821260VITOFITK821259VITASANK821490SILKAFIX ADHESIVE PLASTERK821257SELOFIX

View all 7 devices →

Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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.

↑