510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915692Substantially Equivalent

Cannulated Drill Bit

W. L. Gore & Associates, Inc., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915692 is the FDA 510(k) clearance record for CANNULATED DRILL BIT, a class I device, cleared for W. L. Gore & Associates, Inc. on under FDA product code HTW (Bit, Drill). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K915692.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HTW Bit, Drill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
W. L. Gore & Associates, Inc. 1500 N. Fourth St., Flagstaff AZ
510(k) summary
Statement
Third party review
No

Clearances, product code HTW

Trailing 12 months

FDA records hold no clearances under product code HTW in the trailing twelve months.

FDA records show no clearances under product code HTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HTW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260