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FDA 510(k)

Tembo Embolic System

K-Number: K253677 · 2025-12-15

ApplicantInstylla, Inc.
Decision Date2025-12-15
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tembo Embolic System is the device name listed in this FDA 510(k) record. The listed applicant is Instylla, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K253677. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tembo Embolic System?

Tembo Embolic System is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Instylla, Inc.. The 510(k) number is K253677.

When did Tembo Embolic System receive FDA 510(k) clearance?

Tembo Embolic System received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253677.

Who is the listed applicant for Tembo Embolic System?

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

What is the FDA product code for Tembo Embolic System?

The FDA product code for Tembo Embolic System is KRD.

Related Clinical Trials

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.

NCT04523350Instylla HES Hypervascular Tumor Pivotal StudyCOMPLETED

Other records listing Instylla, 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.

K261610Verge™ MicrocatheterPMA P250003Embolization Agent, VascularK253769Instylla Delivery KitK240873TEMBO Embolic SystemK213632Instylla Delivery KitK210808Instylla Microcatheter 1.2

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.

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