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FDA 510(k)

MEDNEXT MICRO-DRILL

K-Number: K943108 · 1994-08-17

ApplicantMednext, Inc.
Decision Date1994-08-17
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEDNEXT MICRO-DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Mednext, Inc.. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K943108. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDNEXT MICRO-DRILL?

MEDNEXT MICRO-DRILL is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Mednext, Inc.. The 510(k) number is K943108.

When did MEDNEXT MICRO-DRILL receive FDA 510(k) clearance?

MEDNEXT MICRO-DRILL received FDA 510(k) clearance on 1994-08-17, under 510(k) number K943108.

Who is the listed applicant for MEDNEXT MICRO-DRILL?

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 MICRO-DRILL?

The FDA product code for MEDNEXT MICRO-DRILL is ERL.

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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 BURK935861MEDNEXT BURK935584MEDNEXT BURK926547MEDNEXT 1000 BONE DISSECTING SYSTEM

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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