FDA 510(k)

LaproGlide™ 一次性モノポーラルPTFEコートラパロスコピックプローブ

K番号: K230621 · 2023-12-01

決定日2023-12-01

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Principals, Inc.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230621. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes?

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Surgical Principals, Inc.. The 510(k) number is K230621.

When did LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes receive FDA 510(k) clearance?

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230621.

Who is the listed applicant for LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes?

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

What is the FDA product code for LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes?

The FDA product code for LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes is GEI.

申請者としてSurgical Principals, Inc.を記載するその他の記録

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