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FDA 510(k)

TYPE 316L COTTER WIRE

K-Number: K864375 · 1987-05-20

ApplicantWinn Hirsch & Assoc.
Decision Date1987-05-20
Product CodeLRN
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TYPE 316L COTTER WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Winn Hirsch & Assoc.. It received FDA 510(k) clearance on 1987-05-20 under 510(k) number K864375. The device is classified under product code LRN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TYPE 316L COTTER WIRE?

TYPE 316L COTTER WIRE is a medical device that received FDA 510(k) clearance on 1987-05-20. The listed applicant is Winn Hirsch & Assoc.. The 510(k) number is K864375.

When did TYPE 316L COTTER WIRE receive FDA 510(k) clearance?

TYPE 316L COTTER WIRE received FDA 510(k) clearance on 1987-05-20, under 510(k) number K864375.

Who is the listed applicant for TYPE 316L COTTER WIRE?

The FDA 510(k) record lists Winn Hirsch & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE 316L COTTER WIRE?

The FDA product code for TYPE 316L COTTER WIRE is LRN.

Related Clinical Trials

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Other records listing Winn Hirsch & Assoc. 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.

K880309TYPE 316L STAINLESS STEEL WIREK832214GAUZE CONVERSION CLASS I-NON-STERILEK832213GAUZE CONVERSION CLASS II STERILEK830511ZANLEX, ZAN-TEX & ZANDEXK812391NEUROSPONGESK812390NEUROSPONGE PADDIE

View all 11 devices →

Related Devices (Code: LRN)

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.

K002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTURET. Korossurgical Instruments Corp.K990355STAINLESS STEEL SOFT SUTURE WIREBregma International Trading Company , Ltd.K971682J-FX CERCLAGE SYSTEMJohnson & Johnson Professionals, Inc.K952783OXBORO-MEDICAL PIN COVERSOxboro Medical Intl., Inc.K942603ORTHOPAEDIC WIRESAcu Med, Inc.K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)Howmedica 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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