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FDA 510(k)

X-T AIR DRILL

K-Number: K905800 · 1991-04-22

ApplicantXomed-Treace, Inc.
Decision Date1991-04-22
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

X-T AIR DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K905800. 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 X-T AIR DRILL?

X-T AIR DRILL is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K905800.

When did X-T AIR DRILL receive FDA 510(k) clearance?

X-T AIR DRILL received FDA 510(k) clearance on 1991-04-22, under 510(k) number K905800.

Who is the listed applicant for X-T AIR DRILL?

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

What is the FDA product code for X-T AIR DRILL?

The FDA product code for X-T AIR DRILL is ERL.

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Other records listing Xomed-Treace, 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.

K940028ENDOSCOPE SHEATHK941407TYMPANOSTOMY (VENTILATION) TUBEK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

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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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