510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942823Substantially Equivalent

Mahe Instruments

Mahe Intl., Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942823 is the FDA 510(k) clearance record for MAHE INSTRUMENTS, a class II device, cleared for Mahe Intl., Inc. on under FDA product code DWG (Electrosurgical Device). FDA records list 3 510(k) clearances for Mahe Intl., Inc., from to . As of , FDA records show no recalls naming K942823.

Clearance record

Decision date
Received
(174 days to decision)
Product code
DWG Electrosurgical Device
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mahe Intl., Inc. 300 James Robertson Pkwy., Nashville TN
510(k) summary
Statement
Third party review
No

Clearances, product code DWG

Trailing 12 months

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

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