ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP— 510(k) K914358

Name: FDA 510(k) clearance K914358
Creator: U.S. Food and Drug Administration
Published: 1991-11-19

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K914358 for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP, Substantially Equivalent on 1991-11-19. Applicant: Hobbs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-01
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K914358

K-number listed on FDA's recall record

Z-0012-2023 — Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412Class 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 K914358.

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