510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934610Substantially Equivalent

Cath Dome Pd- Water Resistant Cover for Indwelling Peritoneal Dialysis Catheters and Transfer Sets

Tabex Industries, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934610 is the FDA 510(k) clearance record for CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS, a class II device, cleared for Tabex Industries, Inc. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 2 510(k) clearances for Tabex Industries, Inc., from to . As of , FDA records show no recalls naming K934610.

Clearance record

Decision date
Received
(361 days to decision)
Product code
FJS Catheter, Peritoneal, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Tabex Industries, Inc. 5050 Poplar Av., Memphis TN
510(k) summary
Statement
Third party review
No

Clearances, product code FJS

Trailing 12 months

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

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