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510(k) K862689

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP by W.L. Gore & Associates, Inc. — Product Code HXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1986
Date Received
July 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screwdriver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by W.L. Gore & Associates, Inc.

  • K250410 — GORE® Tri-Lobe Balloon Catheter (June 2, 2025)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 2017)

Other clearances for product code HXX

  • K901166 — DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (June 13, 1990)
  • K873066 — ACROMED SCREW DRIVER (September 2, 1987)
  • K872389 — PRECISION SCREW DRIVER SET (July 15, 1987)