← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K963499 # MIRROR FINISH BIPOLAR FORCEPS (K963499) _Johnson & Johnson Professionals, Inc. · GEI · Oct 8, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963499 ## Device Facts - **Applicant:** Johnson & Johnson Professionals, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Oct 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use These Mirror Finish Bipolar Forceps are indicated for use in any surgical procedure that requires tissue coagulation and/or cauterization to achieve hemostasis. They are indicated for use in: 1. general surgery, 2. neurosurgery, 3. urology, and nephrology. ## Device Story Mirror Finish Bipolar Forceps are reusable electrosurgical instruments used by surgeons to achieve hemostasis via tissue coagulation/cauterization. Device consists of stainless steel or titanium forceps with proprietary mirror-finish coated tips designed for non-stick performance. Operated by surgeons in clinical settings (OR); device connects to electrosurgical generators to deliver bipolar energy. Mirror finish coating reduces tissue adhesion during coagulation, facilitating surgical workflow and potentially reducing tissue trauma compared to standard forceps. ## Clinical Evidence Bench testing only. Functional testing and mechanical property analysis demonstrate equivalence to predicate devices. ## Technological Characteristics Materials: Stainless steel or titanium. Design: Bayonet or straight shape; tip sizes 0.25mm–2mm. Energy: Bipolar electrosurgical. Feature: Proprietary mirror-finish tip coating for non-stick properties. Reusable. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - JJPI Bipolar Forceps Line ([K963499](/device/K963499.md)) - KIRWAN Non-Stick Bipolar Forceps ([K963499](/device/K963499.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K963499 # Summary of Safety & Effectiveness Data for the Mirror Finish Bipolar Forceps Line OCT - 8 1996 Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350 1. Contact Person Jennifer Morse, Assoc. Regulatory Affairs Specialist, (508) 880-8417. 2. Device Name Proprietary Name: Mirror Finish Bipolar Forceps Common Name: Bipolar Forceps Classification Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II by 21 CFR § 878.4400 Product Code: 79 GEI Owner/Operator #: 9001269 3. Device Classification Classification for bipolar forceps has been placed in Class II by 21 CFR § 878.4400 4. Statement of Substantial Equivalence The safety and effectiveness of the JJPI Mirror Finish Bipolar Forceps is substantiated by similarity in its intended use and function to the JJPI Bipolar Forceps Line and the KIRWAN Non-Stick Bipolar Forceps. The functional testing and the basic mechanical properties exhibited by the JJPI non-stick forceps indicate that the JJPI proprietary coated tips are functionally equivalent to both the JJPI Bipolar Forceps Line and the KIRWAN Non-Stick Bipolar Forceps. 5. Indications for Use These Mirror Finish Bipolar Forceps are indicated for use in any surgical procedure that requires tissue coagulation and/or cauterization to achieve hemostasis. They are indicated for use in: 1. general surgery, 2. neurosurgery, 3. urology, and nephrology. {1} 6. Physical Description The JJPI Bipolar Forceps Line is a modification of the bipolar forceps we currently have on the market. These forceps are made of either stainless steel or titanium. *The only difference* between our currently marketed line of bipolar forceps and the new line under consideration is the mirror finish proprietary coating that is applied to the tips. Similarities and Differences Matrix | Features | JJPI Mirror Finish Bipolar Forceps | JJPI Bipolar Forceps Line | Kirwan Non-Stick Bipolar Forceps | | --- | --- | --- | --- | | DESIGN | | | | | Tips highly polished | Yes | Yes | Yes | | Non-Stick qualities | Yes | Yes | Yes | | Tip size | 0.25 mm - 2 mm | 0.25 mm. - 2 mm | 0.5 mm. - 2 mm | | Forceps Shape | Bayonet and straight | Bayonet and straight | Bayonet and straight | | Reusable | Yes | Yes | Yes | | | | | | | INTENDED USE | | | | | Indicated for use in any surgical procedure which requires tissue coagulation and/or cauterization to achieve hemostasis. | Yes | Yes | Yes | | They are indicated for use in: 1. general surgery, 2. neurosurgery, 3. urology, and nephrology. | Yes | Yes | Yes | | | | | | | MATERIALS | | | | | Nickel | No | No | Yes | | Stainless Steel, Titanium | Yes | Yes | No | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963499](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963499) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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