SELECTA-TIP LAPAROSCOPIC SCISSORS

K970826 · Microline Pentax, Inc. · GEI · Mar 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970826
• Device Name: SELECTA-TIP LAPAROSCOPIC SCISSORS
• Applicant: Microline Pentax, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Indications for Use

Selecta-Tip Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

Device Story

Manual detachable surgical instrument system; reusable handles attach to interchangeable scissors tips. Tip configurations include Metzenbaum, Mini, Hook, Endocut, and Micro. Proprietary single thread and ball attachment mechanism. Used by surgeons in endoscopic/laparoscopic procedures to cut/dissect tissue. Device provides mechanical cutting functionality; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument; reusable stainless steel components; proprietary single thread and ball attachment system; mechanical cutting action; non-powered; manual operation.

Indications for Use

Indicated for cutting and dissecting abdominal tissue during endoscopic and laparoscopic surgical procedures via cannula access.

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

• Re-New (K962119)

Submission Summary (Full Text)

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10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
K 97 0826

# A. Submitter Information

Microline, Inc.
181 Elliott Street
Beverly, MA 01915
Telephone: [phone]

Contact Person: Mr. Huges de Laforcade
President
Date Prepared: March 3, 1997

MAR 28 1997

# B. Device Identification

Common/Usual Name: Manual Detachable Surgical Instruments
Proprietary Name: "Selecta-Tip" Laparoscopic Scissors Tips

# C. Identification of Predicate Device(s)

The "Selecta-Tip" Laparoscopic Instruments are substantially equivalent to their predicate, "Re-New (K962119), previously cleared and currently marketed.

# D. Device Description

The Selecta-Tip" Laparoscopic Scissors are surgical blades 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 reusable tips.

The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include:

- Metzenbaum,
- Mini,
- Hook,
- Endocut, and
- Micro.

# E. Substantial Equivalence

The technical characteristics of the "Selecta-Tip" Laparoscopic scissors tips are almost identical to those of the Microline "Re-New". Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Selecta-Tip" relative to its predicate.

"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

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