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)

ETHICON EXTERNAL FIXATION WIRE

K-Number: K821178 · 1983-06-11

ApplicantETHICON, Inc.
Decision Date1983-06-11
Product CodeFYI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHICON EXTERNAL FIXATION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1983-06-11 under 510(k) number K821178. The device is classified under product code FYI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHICON EXTERNAL FIXATION WIRE?

ETHICON EXTERNAL FIXATION WIRE is a medical device that received FDA 510(k) clearance on 1983-06-11. The listed applicant is ETHICON, Inc.. The 510(k) number is K821178.

When did ETHICON EXTERNAL FIXATION WIRE receive FDA 510(k) clearance?

ETHICON EXTERNAL FIXATION WIRE received FDA 510(k) clearance on 1983-06-11, under 510(k) number K821178.

Who is the listed applicant for ETHICON EXTERNAL FIXATION WIRE?

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

What is the FDA product code for ETHICON EXTERNAL FIXATION WIRE?

The FDA product code for ETHICON EXTERNAL FIXATION WIRE is FYI.

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 ETHICON, 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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureK252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceK243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

View all 195 devices →

Related Devices (Code: FYI)

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.

K871073OMEGA BIVALVE NASAL SPLINTSOmega Silicone, Inc.K801072STRAITH NASAL SPLINTSurgical Technology Laboratories, Inc.K792106CONPHAR O.R. HEAD COVER-STERILEConphar, 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.

↑