510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070457Substantially Equivalent

Sun Scientific Llc-Leg Compressor and Pfab

Sun-Scientific Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070457 is the FDA 510(k) clearance record for SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB, a class I device, cleared for Sun Scientific, LLC on under FDA product code MHW (Dressing, Compression). FDA records list 3 510(k) clearances for Sun Scientific, LLC, from to . As of , FDA records show no recalls naming K070457.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MHW Dressing, Compression
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Applicant
Sun Scientific, LLC 543 Long Hill Ave., Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHW

Trailing 12 months

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

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