MIRROR FINISH BIPOLAR FORCEPS
K963499 · Johnson & Johnson Professionals, Inc. · GEI · Oct 8, 1996 · General, Plastic Surgery
Device Facts
| Record ID | K963499 |
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| Device Name | MIRROR FINISH BIPOLAR FORCEPS |
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| Applicant | Johnson & Johnson Professionals, Inc. |
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| Product Code | GEI · General, Plastic Surgery |
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| Decision Date | Oct 8, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 878.4400 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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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.
Indications for Use
Indicated for patients undergoing surgical procedures requiring tissue coagulation or cauterization for hemostasis, including general surgery, neurosurgery, urology, and nephrology.
Regulatory Classification
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)
- KIRWAN Non-Stick Bipolar Forceps (K963499)
Related Devices
- K051429 — CLARIS NON-STICK BIPOLAR FORCEPS · Guenter Bissinger Medizintechnik GmbH · Jul 29, 2005
- K083162 — STINGRAY ELECTROSURGICAL FORCEPS · Stingray Surgical Products, Inc. · Jan 12, 2009
- K982705 — MIDAS TOUCH BIPOLAR FORCEPS · Iti Medical Technologies, Inc. · Sep 8, 1998
- K032327 — MODERN MEDICAL BIPOLAR FORCEPS · Modern Medical Equipment Mfg., Ltd. · Jun 15, 2004
- K101080 — NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX · Egon Faulhaber Surgical Instruments Pinzetten · Jun 21, 2010
Submission Summary (Full Text)
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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.
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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 |
