510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921461Substantially Equivalent

Turkel Thoracentesis Needle

Boston Scientific Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921461 is the FDA 510(k) clearance record for TURKEL THORACENTESIS NEEDLE, a class II device, cleared for Symbiosis Corp. on under FDA product code GSS (Antisera, Fluorescent, Pseudomonas Aeruginosa). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K921461.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GSS Antisera, Fluorescent, Pseudomonas Aeruginosa
Regulation
21 CFR 866.3415
Device class
Class II
Review panel
Microbiology
Applicant
Symbiosis Corp. 8600 NW 41 St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code GSS

Trailing 12 months

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

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