510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071167Unknown

Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model Cf-5560

Medigroup, Oswego IL / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071167 is the FDA 510(k) clearance record for FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560, a class II device, cleared for Medigroup, Inc. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 15 510(k) clearances for Medigroup, Inc., from to . As of , FDA records show no recalls naming K071167.

Clearance record

Decision date
Received
(127 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
Medigroup, Inc. 14 A Stonehill Rd., Oswego IL
510(k) summary
Summary PDF
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