HOBBS MISTIFIER SPRAY CATHETER— 510(k) K030765

Name: FDA 510(k) clearance K030765
Creator: U.S. Food and Drug Administration
Published: 2003-06-09

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K030765 for HOBBS MISTIFIER SPRAY CATHETER, Substantially Equivalent on 2003-06-09. Applicant: Hobbs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-11
Decision date: 2003-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K030765

K-number listed on FDA's recall record

Z-0010-2023 — Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190Class II·Ongoing·Hobbs Medical, Inc.·20220729
Z-0011-2023 — Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191Class II·Ongoing·Hobbs Medical, Inc.·20220729

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030765.

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