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FDA 510(k)

MENISCAL SUTURE GUN

K-Number: K832978 · 1983-12-12

ApplicantInstrument Makar, Inc.
Decision Date1983-12-12
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENISCAL SUTURE GUN 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 1983-12-12 under 510(k) number K832978. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENISCAL SUTURE GUN?

MENISCAL SUTURE GUN is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K832978.

When did MENISCAL SUTURE GUN receive FDA 510(k) clearance?

MENISCAL SUTURE GUN received FDA 510(k) clearance on 1983-12-12, under 510(k) number K832978.

Who is the listed applicant for MENISCAL SUTURE GUN?

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 MENISCAL SUTURE GUN?

The FDA product code for MENISCAL SUTURE GUN is GDF.

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Other records listing Instrument Makar, Inc. as applicant

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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: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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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