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)

J-FX BIPOLAR HEAD

K-Number: K980801 · 1998-05-29

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1998-05-29
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

J-FX BIPOLAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1998-05-29 under 510(k) number K980801. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J-FX BIPOLAR HEAD?

J-FX BIPOLAR HEAD is a medical device that received FDA 510(k) clearance on 1998-05-29. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K980801.

When did J-FX BIPOLAR HEAD receive FDA 510(k) clearance?

J-FX BIPOLAR HEAD received FDA 510(k) clearance on 1998-05-29, under 510(k) number K980801.

Who is the listed applicant for J-FX BIPOLAR HEAD?

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

What is the FDA product code for J-FX BIPOLAR HEAD?

The FDA product code for J-FX BIPOLAR HEAD is KWY.

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 Johnson & Johnson Professionals, 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.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

View all 206 devices →

Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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.

↑