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FDA 510(k)

GABBAY-FRATER SUTURE GUIDE

K-Number: K802093 · 1980-09-26

ApplicantHowmedica Corp.
Decision Date1980-09-26
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GABBAY-FRATER SUTURE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802093. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GABBAY-FRATER SUTURE GUIDE?

GABBAY-FRATER SUTURE GUIDE is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Howmedica Corp.. The 510(k) number is K802093.

When did GABBAY-FRATER SUTURE GUIDE receive FDA 510(k) clearance?

GABBAY-FRATER SUTURE GUIDE received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802093.

Who is the listed applicant for GABBAY-FRATER SUTURE GUIDE?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GABBAY-FRATER SUTURE GUIDE?

The FDA product code for GABBAY-FRATER SUTURE GUIDE is FZX.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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