510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950042Substantially Equivalent

Swan Neck Presternal Peritoneal Dialysis Catheter

Accurate Surgical Instruments Co., Toronto Canado M5v 1y9, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950042 is the FDA 510(k) clearance record for SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER, a class II device, cleared for Accurate Surgical Instruments Co. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 9 510(k) clearances for Accurate Surgical Instruments Co., from to . As of , FDA records show no recalls naming K950042.

Clearance record

Decision date
Received
(344 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
Accurate Surgical Instruments Co. 590 Richmond St. W., Toronto Canado M5v 1y9, CA
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