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FDA 510(k)

MCKNIFE

K-Number: K853103 · 1985-08-06

ApplicantMedical Dimensions
Decision Date1985-08-06
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MCKNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dimensions. It received FDA 510(k) clearance on 1985-08-06 under 510(k) number K853103. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCKNIFE?

MCKNIFE is a medical device that received FDA 510(k) clearance on 1985-08-06. The listed applicant is Medical Dimensions. The 510(k) number is K853103.

When did MCKNIFE receive FDA 510(k) clearance?

MCKNIFE received FDA 510(k) clearance on 1985-08-06, under 510(k) number K853103.

Who is the listed applicant for MCKNIFE?

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

What is the FDA product code for MCKNIFE?

The FDA product code for MCKNIFE is GDX.

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 Medical Dimensions 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.

K844236PRISTINE

Related Devices (Code: GDX)

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.

K923689SURGISTAR BLADESSurgistar, Inc.K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical Technologies

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.

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