510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981115Substantially Equivalent

Radio-Plast

Smith & Nephew, Inc., Germantown WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981115 is the FDA 510(k) clearance record for RADIO-PLAST, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K981115.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LHN System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Smith & Nephew, Inc. N104 W13400 Donges Bay Rd., Germantown WI
510(k) summary
Summary
Third party review
No

Clearances, product code LHN

Trailing 12 months
4 clearances under product code LHN in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260