RUSCH MMG/O'NEIL CATHETER— 510(k) K010420

Substantially Equivalent

Rusch, Inc.

FDA 510(k) clearance K010420 for RUSCH MMG/O'NEIL CATHETER, Substantially Equivalent on 2001-05-09. Applicant: Rusch, Inc.. Device class: 2.

Clearance details

Applicant: Rusch, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-12
Decision date: 2001-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K010420

K-number listed on FDA's recall record

Z-0227-2023 — Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.Class II·Ongoing·TELEFLEX LLC·20220920
Z-0771-2017 — RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterizationClass II·Terminated·Teleflex Medical·20161122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010420.

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