510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881359Substantially Equivalent

Decalcifying Solution II

Stephens Scientific, Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881359 is the FDA 510(k) clearance record for DECALCIFYING SOLUTION II, a class I device, cleared for Stephens Scientific on under FDA product code KOX (Solvent, Adhesive Tape). FDA records list 4 510(k) clearances for Stephens Scientific, from to . As of , FDA records show no recalls naming K881359.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KOX Solvent, Adhesive Tape
Regulation
21 CFR 878.4730
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Stephens Scientific 7 Astro Pl., P.O. Box 1116, Denville NJ
Third party review
No

Clearances, product code KOX

Trailing 12 months

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

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