510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130354Substantially Equivalent

Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)

Entrigue Surgical, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130354 is the FDA 510(k) clearance record for MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR), a class I device, cleared for Entrigue Surgical, Inc. on under FDA product code LYA (Splint, Intranasal Septal). FDA records list 4 510(k) clearances for Entrigue Surgical, Inc., from to . As of , FDA records show no recalls naming K130354.

Clearance record

Decision date
Received
(106 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Entrigue Surgical, Inc. 12672 Silicon Dr. Suite 150, San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LYA

Trailing 12 months

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

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