510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K936206Substantially Equivalent

Gore Smoother Crucial Tool

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

K936206 is the FDA 510(k) clearance record for GORE SMOOTHER CRUCIAL TOOL, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K936206.

Clearance record

Decision date
Received
(84 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
W. L. Gore & Associates, Inc. P.O. Box 3000, Flagstaff AZ
510(k) summary
Statement
Third party review
No

Clearances, product code HRX

Trailing 12 months
9 clearances under product code HRX in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20262
November 20260