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FDA 510(k)

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes

K-Number: K230621 · 2023-12-01

ApplicantSurgical Principals, Inc.
Decision Date2023-12-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Surgical Principals, Inc. as applicant

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Official Source

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