510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852527Substantially Equivalent

Satalec Septosonic Sc 80/Sc 120

Spelna, Inc., Fredericksburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852527 is the FDA 510(k) clearance record for SATALEC SEPTOSONIC SC 80/SC 120, a class I device, cleared for Spelna, Inc. on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 11 510(k) clearances for Spelna, Inc., from to . As of , FDA records show no recalls naming K852527.

Clearance record

Decision date
Received
(203 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Spelna, Inc. P.O. Box 3395, Fredericksburg VA
Third party review
No

Clearances, product code FLG

Trailing 12 months

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

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