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FDA 510(k)

INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM

K-Number: K905365 · 1991-02-06

ApplicantInstrument Makar, Inc.
Decision Date1991-02-06
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1991-02-06 under 510(k) number K905365. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM?

INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-02-06. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K905365.

When did INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM receive FDA 510(k) clearance?

INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM received FDA 510(k) clearance on 1991-02-06, under 510(k) number K905365.

Who is the listed applicant for INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM?

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

What is the FDA product code for INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM?

The FDA product code for INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM is KYZ.

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Other records listing Instrument Makar, 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

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Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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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