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FDA 510(k)

angiOCCLUDE Ligating Clips

K-Number: K230966 · 2023-09-19

ApplicantA2 Medical Systems, LLC
Decision Date2023-09-19
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

angiOCCLUDE Ligating Clips is the device name listed in this FDA 510(k) record. The listed applicant is A2 Medical Systems, LLC. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K230966. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the angiOCCLUDE Ligating Clips?

angiOCCLUDE Ligating Clips is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is A2 Medical Systems, LLC. The 510(k) number is K230966.

When did angiOCCLUDE Ligating Clips receive FDA 510(k) clearance?

angiOCCLUDE Ligating Clips received FDA 510(k) clearance on 2023-09-19, under 510(k) number K230966.

Who is the listed applicant for angiOCCLUDE Ligating Clips?

The FDA 510(k) record lists A2 Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for angiOCCLUDE Ligating Clips?

The FDA product code for angiOCCLUDE Ligating Clips is FZP.

Other records listing A2 Medical Systems, LLC 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.

K220006angioLOCK Polymer Ligating Clip

Related Devices (Code: FZP)

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.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int

Official Source

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

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