FDA 510(k)

生物球膠；生物球MIS膠

K 號：K241167 · 2024-12-20

決定日期2024-12-20

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

BioSphere Putty; BioSphere MIS Putty is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Biomedical. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241167. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioSphere Putty; BioSphere MIS Putty?

BioSphere Putty; BioSphere MIS Putty is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Synergy Biomedical. The 510(k) number is K241167.

When did BioSphere Putty; BioSphere MIS Putty receive FDA 510(k) clearance?

BioSphere Putty; BioSphere MIS Putty received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241167.

Who is the listed applicant for BioSphere Putty; BioSphere MIS Putty?

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

What is the FDA product code for BioSphere Putty; BioSphere MIS Putty?

The FDA product code for BioSphere Putty; BioSphere MIS Putty is MQV.

其他以 Synergy Biomedical 為申請人之記錄

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K173424生物球Flex

相關器械（代碼：MQV）

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。

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