← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K962119 # RE-NEW LAPAROSCOPIC INSTRUMENTS (K962119) _Microline Pentax, Inc. · GEI · Aug 9, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962119 ## Device Facts - **Applicant:** Microline Pentax, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Aug 9, 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 “Re-New” Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. ## Device Story Manual detachable surgical instruments for endoscopic/laparoscopic procedures; system comprises reusable handles and interchangeable surgical tips (disposable or reusable). Tip attachment via proprietary double-thread mechanism. Tip styles include Metzenbaum, Mini, Hook, Endocut, and Micro. Used by surgeons in OR settings to cut/dissect abdominal tissue. Flushing port included for cleaning. Device provides mechanical cutting/dissecting capability; standard electrocautery compatibility. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Manual surgical instruments; 5mm diameter; 34cm/42cm length options. Reusable handle/shaft with proprietary double-thread tip attachment. Includes flushing port for cleaning. Compatible with standard electrocautery. ## 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 - Quick Switch ([K932648](/device/K932648.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} AUG - 9 1996 K 96 2119 10. **SMDA Summary of Safety and Effectiveness - "510(k) Summary"** A. **Submitter Information** Microline, Inc. 181 Elliott Street Beverly, MA 01915 Telephone: (508) 922-9810 Contact Person: Mr. Huges de Laforcade President Date Prepared: May 24, 1996 B. **Device Identification** Common/Usual Name: Manual Detachable Surgical Instruments Proprietary Name: “Re-New” Laparoscopic Instruments C. **Identification of Predicate Device(s)** The “Re-New” Laparoscopic Instruments are substantially equivalent to their predicate, “Quick Switch” (K932648, previously cleared and currently marketed. D. **Device Description** The “Re-New” Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include: - disposable tips, and - reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: - Metzenbaum, - Mini, - Hook, - Endocut, and, - Micro. {1} E. Substantial Equivalence The technical characteristics of the "Re-New" Laparoscopic Instruments are almost identical to those of the Microline "Quick Switch". Refer to Table A for a comparison with their predicate. Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Re-New" relative to its predicate. The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. 000013 {2} Table A Comparison Table: Manual Detachable Surgical Instruments | Manufacturer: | Microline, Inc. | Microline, Inc. | | --- | --- | --- | | Model | “Quick-Switch” | “Re-New” | | K-Number | K932648 | | | Class | II | Request II | | Handle/Shaft: | | | | Length (cm) | | | | Disposable | 32 | 34,42 | | Reusable | 32 | 34,42 | | Diameter (mm) | 5 | 5 | | Reusable Handles | Yes | Yes | | Flushing Port for Cleaning | Yes | Yes | | Tips: | | | | Tip Length Range (cm) | | | | Disposable | 3.5 | 4.0 - 4.5 | | Reusable | 3.5 | 4.1 - 4.5 | | Styles | Scissors | Scissors | | Electrocautery | Standard | Standard | | Disposable Assembly | Tips | Tips | | Clinicals: | | | | Clinical Claims | Endoscopic (inclusive of laparoscopic) Surgical Procedures | Endoscopic (inclusive of laparoscopic) Surgical Procedures | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962119](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962119) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com