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FDA 510(k)

MENISCUS MENDER II LOOP

K-Number: K885311 · 1989-02-09

ApplicantInstrument Makar, Inc.
Decision Date1989-02-09
Product CodeHWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENISCUS MENDER II LOOP 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 1989-02-09 under 510(k) number K885311. The device is classified under product code HWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENISCUS MENDER II LOOP?

MENISCUS MENDER II LOOP is a medical device that received FDA 510(k) clearance on 1989-02-09. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K885311.

When did MENISCUS MENDER II LOOP receive FDA 510(k) clearance?

MENISCUS MENDER II LOOP received FDA 510(k) clearance on 1989-02-09, under 510(k) number K885311.

Who is the listed applicant for MENISCUS MENDER II LOOP?

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 MENISCUS MENDER II LOOP?

The FDA product code for MENISCUS MENDER II LOOP is HWQ.

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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: HWQ)

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.

K970360MITEK SUTURE RETROGRADERMitek ProductsK923381SOFT TISSUE EXPANDERAcufex Microsurgical, Inc.K920621ACUFEX PASSING PINS AND SURGICAL WIREAcufex Microsurgical, Inc.K843592VICO MICRO SURGICAL INSTRUMENTSVisitec Co.K841622SOFT-TISSUE INSTRUMENTPlastafil, Inc.K841623SLOTTED SOFT-TISSUE INSTRUMENTPlastafil, 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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