510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983647Substantially Equivalent

Echo-Coat Ultrasound Needles

Sts Biopolymers, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983647 is the FDA 510(k) clearance record for ECHO-COAT ULTRASOUND NEEDLES, a class I device, cleared for Sts Biopolymers on under FDA product code MJG (Device, Percutaneous, Biopsy). FDA records list one 510(k) clearance for Sts Biopolymers. As of , FDA records show no recalls naming K983647.

Clearance record

Decision date
Received
(96 days to decision)
Product code
MJG Device, Percutaneous, Biopsy
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sts Biopolymers 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code MJG

Trailing 12 months

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

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