510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924702Substantially Equivalent

Turkel Abdominal Paracentesis System

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

K924702 is the FDA 510(k) clearance record for TURKEL ABDOMINAL PARACENTESIS SYSTEM, a class I device, cleared for Symbiosis Corp. on under FDA product code GBX (Catheter, Irrigation). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K924702.

Clearance record

Decision date
Received
(117 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Symbiosis Corp. 8600 NW 41 St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code GBX

Trailing 12 months

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

FDA records show no clearances under product code GBX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GBX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260