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
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K070315Substantially Equivalent

Lina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8

LiNA Medical Inc, Chapel Hill NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070315 is the FDA 510(k) clearance record for LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8, a class II device, cleared for Lina Medical Aps on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 16 510(k) clearances for Lina Medical Aps, from to . As of , FDA records show 3 recalls naming K070315.

Clearance record

Decision date
Received
(271 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lina Medical Aps 1289 N Fordham Blvd., Chapel Hill NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260