510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K961628Substantially Equivalent

Mini Flex Coil

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

K961628 is the FDA 510(k) clearance record for MINI FLEX COIL, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K961628.

Clearance record

Decision date
Received
(132 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
W. L. Gore & Associates, Inc. 4747 E. Beautiful Ln., Phoenix AZ
510(k) summary
Summary
Third party review
No

Clearances, product code MOS

Trailing 12 months
10 clearances under product code MOS in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20261
November 20260