FDA 510(k)

KIRSCHNER WIRE

K-Number: K801010 · 1980-05-20

ApplicantAmerican Safety Equipment Corp.

Decision Date1980-05-20

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KIRSCHNER WIRE is the device name listed in this FDA 510(k) record. The listed applicant is American Safety Equipment Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801010. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRSCHNER WIRE?

KIRSCHNER WIRE is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is American Safety Equipment Corp.. The 510(k) number is K801010.

When did KIRSCHNER WIRE receive FDA 510(k) clearance?

KIRSCHNER WIRE received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801010.

Who is the listed applicant for KIRSCHNER WIRE?

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

What is the FDA product code for KIRSCHNER WIRE?

The FDA product code for KIRSCHNER WIRE is HSB.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Safety Equipment Corp. as applicant

K771699CARA-STAIN MODEL 3000 K760960SURGICAL WIRE DRIVER K760956SURGICAL MICRO DRILL K760958SURGICAL OSCILLATING SAW K760959SURGICAL CHISEL K760957SURGICAL RECIPROCATING SAW

View all 7 devices →

Related Devices (Code: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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.