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FDA 510(k)

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

K-Number: K963246 · 1996-09-23

ApplicantMedtronic Xomed
Decision Date1996-09-23
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K963246. 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 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT?

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Medtronic Xomed. The 510(k) number is K963246.

When did TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT receive FDA 510(k) clearance?

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT received FDA 510(k) clearance on 1996-09-23, under 510(k) number K963246.

Who is the listed applicant for TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT?

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

What is the FDA product code for TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT?

The FDA product code for TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT is ERL.

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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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