TITANIUM CONNECTOR (2 PART)— 510(k) K910787

Clearance details

Applicant

Accurate Surgical Instruments Co.

Product code

Code FKO

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

1991-02-25

Decision date

1991-08-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Toronto Canado M5v 1y9, CA

• K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS1998-06-26
• K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR1998-02-27
• K885037 — AMUKIN 50% - AIRSPRAY(R)1990-10-19
• K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)1987-12-09
• K872221 — DIALY-NATE SET & DIALY-NATE CATHETER1987-10-13

• K950042 — SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER1995-12-15
• K920515 — INSERTION1992-05-04
• K910786 — TROCAR (FALLER STYLET)1991-09-19
• K910785 — TITANIUM CATHETER EXTENDER1991-08-22
• K862046 — SWAN-NECK PERITONEAL DIALYSIS CATHETERS1986-06-19

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →