510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961392Substantially Equivalent

Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II

Sil-Med Corp., Taunton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961392 is the FDA 510(k) clearance record for ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II, a class II device, cleared for Sil-Med Corp. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 29 510(k) clearances for Sil-Med Corp., from to . As of , FDA records show no recalls naming K961392.

Clearance record

Decision date
Received
(463 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
Sil-Med Corp. 700 Warner Blvd., Taunton MA
510(k) summary
Summary
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