BK-6010 CATHETER TUBE HOLDER— 510(k) K801711

Name: FDA 510(k) clearance K801711
Creator: U.S. Food and Drug Administration
Published: 1980-08-13

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K801711 for BK-6010 CATHETER TUBE HOLDER, Substantially Equivalent on 1980-08-13. Applicant: Fred Sammons, Inc.. Device class: 2.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1980-07-24
Decision date: 1980-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNX

view all

K110518 — IBAG2011-06-24
K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG1998-03-17
K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG1997-12-11
K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM1997-08-18
K971929 — AMSINO URINARY LEG BAG1997-08-06

More clearances from Fred Sammons, Inc.

view all

K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)1988-05-06
K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)1988-04-01
K831549 — ARM SLINGS1983-06-30
K831548 — SPLINTS1983-06-27
K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE1983-06-24

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.