← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K960009 # STORZ S2050 SERIES BIPOLAR FORCEPS (K960009) _Storz Instrument Co. · GEI · Mar 6, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960009 ## Device Facts - **Applicant:** Storz Instrument Co. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Mar 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested. ## Device Story Reusable bipolar forceps; used with electrosurgical generators (Storz DAISY, Protegé, PREMIERE, S2080). Device functions by pinching tissue between stainless steel tips; high-frequency electric current passes through tissue to achieve coagulation and hemostasis. Operated by surgeons in OR settings. Output is physical tissue coagulation; provides surgeon control over bleeding during microsurgery. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Materials: 410 and 17-7 stainless steel; nylon insulation on handle. Energy: High-frequency electric current. Connectivity: Two-pin male connector for electrosurgical generators. Reusable. Form factor: Various tip configurations and handle dimensions. ## 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 - Kirwan Bipolar Forceps (Kirwan Surgical Products, Inc.) - Mentor O&O WET-FIELD Bipolar Forceps (Mentor O&O, Inc.) ## 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} story K 960009 MAR - 6 1996 # 510(k) Summary of Safety and Effectiveness The following information is submitted in accordance with 21 CFR 807.92: ## Submitted by: Audrey G. Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 314/225-5051 ![img-0.jpeg](img-0.jpeg) ## Contact Person: Audrey G. Swearingen Regulatory Affairs Associate ## Date Prepared: February 12, 1996 ## Proprietary Name: Storz S2050 series Bipolar Forceps ## Common/Usual Name: Bipolar coagulation forceps ## Classification Name: Electrosurgical Device, Cutting and Coagulation, and Accessories; 79(GEI) ## Device Description: Storz S2050 series of bipolar forceps consists of twenty-one reusable devices for use with Storz DAISY™, Protegé®, and PREMIERE® Microsurgical Systems, and Storz S2080 Bipolar Coagulator. All forceps are of the same basic design with differences in tip configurations and handle dimensions. The patient contact portion of the S2050 series of forceps is composed of stainless steel. Some models have a nylon insulation on the handle region of the forceps. ## Intended Use: The Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested. ## Predicate Devices: The Kirwan Bipolar Forceps (Kirwan Surgical Products, Inc.); and the Mentor O&O WET-FIELD Bipolar Forceps (Mentor O&O, Inc.). ## Predicate Comparison: A table comparing the Storz S2050 series Bipolar Forceps to predicate devices, demonstrating substantial equivalence, is attached. STORZ 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6604 (314) 225-5051 Telex 981491 STORZ STI FAX (314) 225-7365 81A {1} 82 # Storz S2050 Bipolar Forceps Substantial Equivalence Comparison | Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. | Mentor O & O, Inc. | | --- | --- | --- | --- | | Device | Storz Bipolar Forceps | Kirwan Bipolar Forceps | Mentor WET-FIELD™ Bipolar Forceps | | Model(s) | S2050-XX series | Complete list of model numbers unknown | 22-12XX series | | Intended Use | Vessel coagulation during surgery | Vessel coagulation during surgery | Vessel coagulation during surgery | | Patient-Contact Material Composition | 410 and 17-7 Stainless steel | Stainless steel; material of “non-stick” models unknown | Unknown | | System(s) for which Device is Designed | Storz DAISY®, Protegé®, and PREMIERE® Microsurgical Systems; and S2080 Bipolar Coagulator | No specific system known | Mentor WET-FIELD II™ Coagulator | | Connector type | Two-pin male connector | Two-pin male connector | Two-pin male connector | | Reusable/Single Use? | Reusable | Reusable | Reusable | | Provided Sterile? | No | No | No | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960009) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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