510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941495Substantially Equivalent

Return Path Diathermy Handle

Mira, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941495 is the FDA 510(k) clearance record for RETURN PATH DIATHERMY HANDLE, a class II device, cleared for Mira, Inc. on under FDA product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered). FDA records list one 510(k) clearance for Mira, Inc. As of , FDA records show no recalls naming K941495.

Clearance record

Decision date
Received
(109 days to decision)
Product code
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
Regulation
21 CFR 886.4100
Device class
Class II
Review panel
Ophthalmic
Applicant
Mira, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code HQR

Trailing 12 months

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

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