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FDA 510(k)

組織統計器

K 號：K231277 · 2023-11-09

申請人Durastat, LLC
決定日期2023-11-09
產品代碼NBY
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

TissueStat is the device name listed in this FDA 510(k) record. The listed applicant is Durastat, LLC. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231277. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TissueStat?

TissueStat is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Durastat, LLC. The 510(k) number is K231277.

When did TissueStat receive FDA 510(k) clearance?

TissueStat received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231277.

Who is the listed applicant for TissueStat?

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

What is the FDA product code for TissueStat?

The FDA product code for TissueStat is NBY.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NBY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K192088GOLNIT 非吸收性聚四氟乙烯外科縫線Antarma, LLC Dba Golnit SuturesK180992生物特克斯Purgo Biologics, Inc.K191317釘織套件Origami SurgicalK181578DemeTECH PTFE 不吸收性外科縫線Demetech CorporationK180630聚四氟乙烯外科縫線Omnia SpaK173922C-PTFETM 外科縫線Cp Medical, Inc.

官方來源

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