510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041704Substantially Equivalent

Newgel and Newgel Plus E

Newmedical Technology, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041704 is the FDA 510(k) clearance record for NEWGEL AND NEWGEL PLUS E, a class I device, cleared for Newmedical Technology, Inc. on under FDA product code MDA (Elastomer, Silicone, For Scar Management). FDA records list 3 510(k) clearances for Newmedical Technology, Inc., from to . As of , FDA records show no recalls naming K041704.

Clearance record

Decision date
Received
(481 days to decision)
Product code
MDA Elastomer, Silicone, For Scar Management
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Newmedical Technology, Inc. 3324 Commercial Ave., Northbrook IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MDA

Trailing 12 months

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

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