510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895502Substantially Equivalent

Microtek Reuter-Style Bi-Valve Intranasal Splint

Microbio-Medics, Inc., Columbus MS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895502 is the FDA 510(k) clearance record for MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT, a class I device, cleared for Microbio-Medics, Inc. on under FDA product code EPP (Splint, Nasal). FDA records list 13 510(k) clearances for Microbio-Medics, Inc., from to . As of , FDA records show no recalls naming K895502.

Clearance record

Decision date
Received
(87 days to decision)
Product code
EPP Splint, Nasal
Regulation
21 CFR 874.5800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Microbio-Medics, Inc. Post Office Box 2487, Columbus MS
Third party review
No

Clearances, product code EPP

Trailing 12 months

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

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