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)

LE VEEN WOUND SPLINT

K-Number: K863570 · 1986-09-29

ApplicantTek-Aid, Inc.
Decision Date1986-09-29
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LE VEEN WOUND SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Tek-Aid, Inc.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863570. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LE VEEN WOUND SPLINT?

LE VEEN WOUND SPLINT is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Tek-Aid, Inc.. The 510(k) number is K863570.

When did LE VEEN WOUND SPLINT receive FDA 510(k) clearance?

LE VEEN WOUND SPLINT received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863570.

Who is the listed applicant for LE VEEN WOUND SPLINT?

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

What is the FDA product code for LE VEEN WOUND SPLINT?

The FDA product code for LE VEEN WOUND SPLINT is KGS.

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

Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, 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.

↑