FDA 510(k)

TroCare TroKit Laparoscope Lens Wiper (CP000626)

K番号: K241796 · 2024-10-04

決定日2024-10-04

製品コードGCJ

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

TroCare TroKit Laparoscope Lens Wiper (CP000626) is the device name listed in this FDA 510(k) record. The listed applicant is TroCare, LLC. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241796. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the TroCare TroKit Laparoscope Lens Wiper (CP000626)?

TroCare TroKit Laparoscope Lens Wiper (CP000626) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is TroCare, LLC. The 510(k) number is K241796.

When did TroCare TroKit Laparoscope Lens Wiper (CP000626) receive FDA 510(k) clearance?

TroCare TroKit Laparoscope Lens Wiper (CP000626) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241796.

Who is the listed applicant for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

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

What is the FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

The FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626) is GCJ.

申請者としてTroCare, LLCを記載するその他の記録

K253994TroKit Laparoscope Lens Wiper

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