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FDA 510(k)

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP

K-Number: K862689 · 1986-09-02

ApplicantW. L. Gore & Associates, Inc.
Decision Date1986-09-02
Product CodeHXX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1986-09-02 under 510(k) number K862689. The device is classified under product code HXX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP?

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP is a medical device that received FDA 510(k) clearance on 1986-09-02. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K862689.

When did 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP receive FDA 510(k) clearance?

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP received FDA 510(k) clearance on 1986-09-02, under 510(k) number K862689.

Who is the listed applicant for 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP?

The FDA product code for 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP is HXX.

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Other records listing W. L. Gore & Associates, 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: HXX)

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.

K901166DALTON TECHNOLOGY FLEXIBLE SCREWDRIVERDalton Technology, Inc.K873066ACROMED SCREW DRIVERBuckman Co., Inc.K872389PRECISION SCREW DRIVER SETMed-Tool, 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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