Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aspiration Catheter (2189)

K-Number: K241874 · 2024-09-24

ApplicantHobbs Medical, Inc.
Decision Date2024-09-24
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aspiration Catheter (2189) is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K241874. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspiration Catheter (2189)?

Aspiration Catheter (2189) is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K241874.

When did Aspiration Catheter (2189) receive FDA 510(k) clearance?

Aspiration Catheter (2189) received FDA 510(k) clearance on 2024-09-24, under 510(k) number K241874.

Who is the listed applicant for Aspiration Catheter (2189)?

The FDA 510(k) record lists Hobbs Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspiration Catheter (2189)?

The FDA product code for Aspiration Catheter (2189) is OCX.

Other records listing Hobbs Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182927Pulmonary Cytology Brush

Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK242134ClearCap Distal AttachmentFinemedix Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑