SIMPLASTIC SUPRA PUBIC CATHETER— 510(k) K852200

Name: FDA 510(k) clearance K852200
Creator: U.S. Food and Drug Administration
Published: 1985-08-07

Substantially Equivalent

Franklin Medical USA, Inc.

FDA 510(k) clearance K852200 for SIMPLASTIC SUPRA PUBIC CATHETER, Substantially Equivalent on 1985-08-07. Applicant: Franklin Medical USA, Inc.. Device class: 2.

Clearance details

Applicant: Franklin Medical USA, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-21
Decision date: 1985-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOB

view all

K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set2024-11-01
K181097 — Cook Cystostomy Catheter Set2019-01-18
K182709 — One-Step Suprapubic Introducer2018-12-26
K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set2018-10-30
K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET2014-01-17

More clearances from Franklin Medical USA, Inc.

view all

K931488 — KSF SPINAL FIXATOR1994-01-21
K884589 — FRANTZ MEDICAL SHARPS COLLECTOR1988-12-09
K862478 — HAYES VAGINAL SHIELD1986-11-24

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