FDA 510(k)

Monik™ - 一次性內視鏡穿刺針

K 號：K233386 · 2024-05-24

申請人M/s. Meril Endo Surgery Private Limited.

決定日期2024-05-24

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Monik™ - Disposable Endoscopic Trocar is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K233386. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Monik™ - Disposable Endoscopic Trocar?

Monik™ - Disposable Endoscopic Trocar is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K233386.

When did Monik™ - Disposable Endoscopic Trocar receive FDA 510(k) clearance?

Monik™ - Disposable Endoscopic Trocar received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233386.

Who is the listed applicant for Monik™ - Disposable Endoscopic Trocar?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monik™ - Disposable Endoscopic Trocar?

The FDA product code for Monik™ - Disposable Endoscopic Trocar is GCJ.

其他以 M/s. Meril Endo Surgery Private Limited. 為申請人之記錄

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相關器械（代碼：GCJ）

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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