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FDA 510(k)

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT

K-Number: K963843 · 1997-03-31

ApplicantMicro Motors, Inc.
Decision Date1997-03-31
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Micro Motors, Inc.. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K963843. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT?

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Micro Motors, Inc.. The 510(k) number is K963843.

When did ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT receive FDA 510(k) clearance?

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT received FDA 510(k) clearance on 1997-03-31, under 510(k) number K963843.

Who is the listed applicant for ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT?

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

What is the FDA product code for ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT?

The FDA product code for ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT is EFB.

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Other records listing Micro Motors, 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.

K000120PRO-TORQK991283DYNA TORQ TORQUE WRENCH, TORQUE WRENCHK970002STERILE WATER PUMPK942380MICRO ICS SONIC SCALERK935676MICRO RSH HIGH SPEED HANDPIECEK91106829540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM

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Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., 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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