510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073610Substantially Equivalent

Elta Advanced Wound Wash

Swiss American Products, Inc., Carrollton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K073610 is the FDA 510(k) clearance record for ELTA ADVANCED WOUND WASH, cleared for Swiss American Products, Inc. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 4 510(k) clearances for Swiss American Products, Inc., from to . As of , FDA records show no recalls naming K073610.

Clearance record

Decision date
Received
(124 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Swiss American Products, Inc. 2055 Luna Rd., Carrollton TX
510(k) summary
Statement
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260