510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910781Substantially Equivalent

#491 Power Otolaryngoly Ch/#498 Proced Ctr & Acces

Midmark Corp, Versailles OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910781 is the FDA 510(k) clearance record for #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES, a class I device, cleared for Midmark Corp. on under FDA product code ETF (Unit, Examining/Treatment, Ent). FDA records list 39 510(k) clearances for Midmark Corp., from to . As of , FDA records show no recalls naming K910781.

Clearance record

Decision date
Received
(79 days to decision)
Product code
ETF Unit, Examining/Treatment, Ent
Regulation
21 CFR 874.5300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Midmark Corp. 60 Vista Dr., Versailles OH
Third party review
No

Clearances, product code ETF

Trailing 12 months

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

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