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FDA 510(k)

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

K-Number: K962163 · 1996-07-25

ApplicantMisten Medical Corp.
Decision Date1996-07-25
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Misten Medical Corp.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962163. 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 MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL?

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Misten Medical Corp.. The 510(k) number is K962163.

When did MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL receive FDA 510(k) clearance?

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962163.

Who is the listed applicant for MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL?

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

What is the FDA product code for MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL?

The FDA product code for MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL is ERL.

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 Misten Medical Corp. 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.

K955616MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBEK955613MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESISK955615MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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