(67 days)
The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.
The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.
This document is a 510(k) summary for a medical device (KSEA Bipolar Coagulating Forceps), not a study report describing acceptance criteria and device performance evaluation based on clinical data.
Therefore, I cannot provide the requested information, which typically pertains to the evaluation of AI/ML-driven devices or diagnostic tools. The content provided describes a surgical instrument and focuses on its design, intended use, and substantial equivalence to predicate devices, rather than a performance study with acceptance criteria.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 | K962396 |
|---|---|---|
| Contact: | Kevin KennanRegulatory Affairs Specialist | AUG 27 1996 |
| Device Identification: | Common Name:Bipolar Forceps | |
| Trade Name: (optional)KSEA Bipolar Coagulating Forceps |
Indication: The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.
Device Description: The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.
Substantial Equivalence: The KSEA Bipolar Coagulating Forceps for endoscopic and non endoscopic ENT surgical procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Bipolar Coagulating Forceps and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Kennan
Regulatory Affairs Specialist
000048
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.