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510(k) Data Aggregation
K Number
K230621Device Name
LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes
Manufacturer
Date Cleared
2023-12-01
(270 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Surgical Principals, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation.
Device Description
The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are sterile packaged single use stainless-steel electrodes coated with a non-stick material (PTFE), which is used to cut and coagulate soft tissue. The PTFE Coating reduced the buildup of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup. These devices have a 5mm diameter with working lengths up to 44cm and includes various tip geometries (L-hook, Spatula, etc.). Additionally, devices are provided in either foot-activated (via a standard 4mm female monopolar connector) or hand-activated (via a standard electrosurgical pencil) versions.
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