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FDA 510(k)

SURGICAL DRILL-ELECTRIC-HANDPIECE

K-Number: K831946 · 1983-11-03

ApplicantEntronics
Decision Date1983-11-03
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRILL-ELECTRIC-HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Entronics. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K831946. 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 SURGICAL DRILL-ELECTRIC-HANDPIECE?

SURGICAL DRILL-ELECTRIC-HANDPIECE is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Entronics. The 510(k) number is K831946.

When did SURGICAL DRILL-ELECTRIC-HANDPIECE receive FDA 510(k) clearance?

SURGICAL DRILL-ELECTRIC-HANDPIECE received FDA 510(k) clearance on 1983-11-03, under 510(k) number K831946.

Who is the listed applicant for SURGICAL DRILL-ELECTRIC-HANDPIECE?

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

What is the FDA product code for SURGICAL DRILL-ELECTRIC-HANDPIECE?

The FDA product code for SURGICAL DRILL-ELECTRIC-HANDPIECE 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 Entronics 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.

K862989SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE

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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