FDA 510(k)

一次性雙動組織夾

K 號：K212748 · 2022-01-20

決定日期2022-01-20

產品代碼PKL

諮詢委員會GU

決定相當於

器材摘要

Disposable Dual Action Tissue Clip is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212748. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Dual Action Tissue Clip?

Disposable Dual Action Tissue Clip is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K212748.

When did Disposable Dual Action Tissue Clip receive FDA 510(k) clearance?

Disposable Dual Action Tissue Clip received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212748.

Who is the listed applicant for Disposable Dual Action Tissue Clip?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Dual Action Tissue Clip?

The FDA product code for Disposable Dual Action Tissue Clip is PKL.

其他以 Micro-Tech (Nanjing) Co., Ltd. 為申請人之記錄

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。

K252492視覺化進入與輸送導管；PB數位控制器 K251692先進組織切除設備 K250229雙動力組織閉合設備 K243388一次性遠端帽 K243471抽獲籃 K230127膽管塑料支架、膽管塑料支架導入器、膽管塑料支架組、膽管塑料支架導入器/短針相容、膽管塑料支架組/短針相容

查看所有 37 項裝置 →

相關器械（代碼：PKL）

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。

K253481結腸FTRD組合（200.70）；診斷FTRD組合（200.76）；胃十二指腸FTRD組合（200.72）Ovesco Endoscopy AG K254069血夾（511系列，543系列）Hangzhou AGS MedTech Co., Ltd.K260580單次使用可重裝夾釘應用器（HX-810LR，HX-810UR）；夾釘（HX-610-090，HX-610-135）；長夾釘（HX-610-090L，HX-610-135L）；短夾釘（HX-610-090S，HX-610-135S）；超短夾釘（HX-610-135XS）Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734泰夫斯克膠片Taurus Endoscopy K251562OTSCneo 系統組合（100.03n-14n，100.27n-31n）Ovesco Endoscopy AG

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。