510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874719Substantially Equivalent

Stratum Esu

Alternative Design Systems, Inc., Carlstadt NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874719 is the FDA 510(k) clearance record for STRATUM ESU, a class II device, cleared for Alternative Design Systems, Inc. on under FDA product code JOS (Electrode, Electrosurgical). FDA records list 6 510(k) clearances for Alternative Design Systems, Inc., from to . As of , FDA records show no recalls naming K874719.

Clearance record

Decision date
Received
(91 days to decision)
Product code
JOS Electrode, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alternative Design Systems, Inc. 419 Hackensack Ave., Carlstadt NJ
Third party review
No

Clearances, product code JOS

Trailing 12 months

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

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