510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953277Substantially Equivalent

Shadow Medal Locator

Fatswith Intl., Inc., Vancouver, Bc,, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953277 is the FDA 510(k) clearance record for SHADOW MEDAL LOCATOR, a class II device, cleared for Fatswith Intl., Inc. on under FDA product code HPM (Locator, Metal, Electronic). FDA records list one 510(k) clearance for Fatswith Intl., Inc. As of , FDA records show no recalls naming K953277.

Clearance record

Decision date
Received
(263 days to decision)
Product code
HPM Locator, Metal, Electronic
Regulation
21 CFR 886.4400
Device class
Class II
Review panel
Ophthalmic
Applicant
Fatswith Intl., Inc. 2370 Maple St., Vancouver, Bc,, CA
510(k) summary
Statement
Third party review
No

Clearances, product code HPM

Trailing 12 months

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

FDA records show no clearances under product code HPM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPM, 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