510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843214Substantially Equivalent

Ephar

Akron City Hospital, Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843214 is the FDA 510(k) clearance record for EPHAR, a class II device, cleared for Akron City Hospital on under FDA product code FFI (System, Alarm, Electrosurgical). FDA records list 2 510(k) clearances for Akron City Hospital, from to . As of , FDA records show no recalls naming K843214.

Clearance record

Decision date
Received
(106 days to decision)
Product code
FFI System, Alarm, Electrosurgical
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Akron City Hospital 525 E. Market St., Akron OH
Third party review
No

Clearances, product code FFI

Trailing 12 months

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

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