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FDA 510(k)

MEDNEXT BUR

K-Number: K935861 · 1994-05-03

ApplicantMednext, Inc.
Decision Date1994-05-03
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDNEXT BUR is the device name listed in this FDA 510(k) record. The listed applicant is Mednext, Inc.. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K935861. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDNEXT BUR?

MEDNEXT BUR is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is Mednext, Inc.. The 510(k) number is K935861.

When did MEDNEXT BUR receive FDA 510(k) clearance?

MEDNEXT BUR received FDA 510(k) clearance on 1994-05-03, under 510(k) number K935861.

Who is the listed applicant for MEDNEXT BUR?

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

What is the FDA product code for MEDNEXT BUR?

The FDA product code for MEDNEXT BUR is HBE.

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.

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Other records listing Mednext, 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.

K983092TRITON HUDSON CHUCK ATTACHMENTK972308MEDNEXT 1000 DRILLK970023MEDNEXT SURGICAL BURK943108MEDNEXT MICRO-DRILLK935584MEDNEXT BURK926547MEDNEXT 1000 BONE DISSECTING SYSTEM

View all 7 devices →

Related Devices (Code: HBE)

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.

K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly Drill (H100)Hubly, Inc.K252060GREENPhasor Health, LLCK252662UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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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