Who is the manufacturer of RE-NEW LAPAROSCOPIC INSTRUMENTS?

Microline Pentax, Inc. filed the 510(k) submission for RE-NEW LAPAROSCOPIC INSTRUMENTS (K962119).

What is the FDA product code for RE-NEW LAPAROSCOPIC INSTRUMENTS?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for RE-NEW LAPAROSCOPIC INSTRUMENTS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RE-NEW LAPAROSCOPIC INSTRUMENTS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RE-NEW LAPAROSCOPIC INSTRUMENTS

K962119 · Microline Pentax, Inc. · GEI · Aug 9, 1996 · General, Plastic Surgery

Device Facts

Record ID	K962119
Device Name	RE-NEW LAPAROSCOPIC INSTRUMENTS
Applicant	Microline Pentax, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Aug 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for use in endoscopic, including laparoscopic, surgical procedures for cutting and dissecting abdominal tissue.

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

Quick Switch (K932648)

Related Devices

K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORS · Microline Pentax, Inc. · Mar 28, 1997
K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS · Covidien Lp, Formerly Registered AS United States · Sep 1, 2009
K123260 — DETACHATIP III · Conmed Corporation · Dec 21, 2012
K151567 — ENDOPLUS hand-held laparoscopic instruments · Endoplus · Dec 23, 2015
K982287 — ASLAN SENSOR MODULAR INSTRUMENT · Aslan Medical Technologies, Ltd. · Aug 6, 1998

Submission Summary (Full Text)

{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 |