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FDA 510(k)

GS & GS20 SURGICAL TOOL SYSTEM

K-Number: K952463 · 1995-07-17

ApplicantMidas Rex Pneumatic Tools, Inc.
Decision Date1995-07-17
Product CodeGET
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GS & GS20 SURGICAL TOOL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Midas Rex Pneumatic Tools, Inc.. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K952463. The device is classified under product code GET. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GS & GS20 SURGICAL TOOL SYSTEM?

GS & GS20 SURGICAL TOOL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Midas Rex Pneumatic Tools, Inc.. The 510(k) number is K952463.

When did GS & GS20 SURGICAL TOOL SYSTEM receive FDA 510(k) clearance?

GS & GS20 SURGICAL TOOL SYSTEM received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952463.

Who is the listed applicant for GS & GS20 SURGICAL TOOL SYSTEM?

The FDA 510(k) record lists Midas Rex Pneumatic Tools, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GS & GS20 SURGICAL TOOL SYSTEM?

The FDA product code for GS & GS20 SURGICAL TOOL SYSTEM is GET.

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Other records listing Midas Rex Pneumatic Tools, 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.

K972289MIDAS REX MOTORK970965MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)K962483MIDAS REX III MOTORK953434MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)K954076MIDAS REX DRILL ATTACHMENTS & TWIST DRILLSK953433MIDAS REX TELESCOPING SYSTEM

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Related Devices (Code: GET)

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.

K960473AESCULAP POWER SYSTEM HANDPIECEAesculap, Inc.K955174SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMYSodem Diffusion SAK942987NUCLEOTOME L KITSurgical Dynamics, Inc.K954076MIDAS REX DRILL ATTACHMENTS & TWIST DRILLSMidas Rex Pneumatic Tools, Inc.K953433MIDAS REX TELESCOPING SYSTEMMidas Rex Pneumatic Tools, Inc.K953432ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLSMidas Rex Pneumatic Tools, Inc.

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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