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)

RADOVAN SUBCUTANEOUS TISSUE EXPANDER

K-Number: K833502 · 1984-02-03

ApplicantAmerican Heyer Schulte
Decision Date1984-02-03
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

RADOVAN SUBCUTANEOUS TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K833502. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

RADOVAN SUBCUTANEOUS TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is American Heyer Schulte. The 510(k) number is K833502.

When did RADOVAN SUBCUTANEOUS TISSUE EXPANDER receive FDA 510(k) clearance?

RADOVAN SUBCUTANEOUS TISSUE EXPANDER received FDA 510(k) clearance on 1984-02-03, under 510(k) number K833502.

Who is the listed applicant for RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

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

What is the FDA product code for RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

The FDA product code for RADOVAN SUBCUTANEOUS TISSUE EXPANDER is LCJ.

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 American Heyer Schulte 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.

K840172VENTRAL WALL DEFECT REDUCT SILOK834593ONE-PIECE SHUNTK833698AMER. V. MUELLER SURG. STAPLES ILAK833704AMER. V. MUELLER SURGICALSTAPLES-CARTRK832738HEYER-SCHULTE AFTERLOADING CATHETERK823790VENTRICULAR ACCESS SYSTEM

View all 13 devices →

Related Devices (Code: LCJ)

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.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, 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.

↑