510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K170270Substantially Equivalent

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

Ls Scientific Inc. D.B.A. Kse Scientific, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170270 is the FDA 510(k) clearance record for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline, cleared for Ls Scientific Inc. D.B.A. Kse Scientific on under FDA product code FRO (Dressing, Wound, Drug). FDA records list one 510(k) clearance for Ls Scientific Inc. D.B.A. Kse Scientific. As of , FDA records show no recalls naming K170270.

Clearance record

Decision date
Received
(147 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Ls Scientific Inc. D.B.A. Kse Scientific 2714 S. Miami Blvd., Durham NC
510(k) summary
Summary PDF
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