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FDA 510(k)

SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE

K-Number: K862989 · 1986-08-21

ApplicantEntronics
Decision Date1986-08-21
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Entronics. It received FDA 510(k) clearance on 1986-08-21 under 510(k) number K862989. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE?

SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE is a medical device that received FDA 510(k) clearance on 1986-08-21. The listed applicant is Entronics. The 510(k) number is K862989.

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

SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE received FDA 510(k) clearance on 1986-08-21, under 510(k) number K862989.

Who is the listed applicant for SURGICAL DRILL (ELECTRIC) INCLUDING 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) INCLUDING HANDPIECE?

The FDA product code for SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE is HBC.

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.

K831946SURGICAL DRILL-ELECTRIC-HANDPIECE

Related Devices (Code: HBC)

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.

K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

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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