Who is the manufacturer of SELECTA-TIP LAPAROSCOPIC SCISSORS?

Microline Pentax, Inc. filed the 510(k) submission for SELECTA-TIP LAPAROSCOPIC SCISSORS (K970826).

What is the FDA product code for SELECTA-TIP LAPAROSCOPIC SCISSORS?

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 SELECTA-TIP LAPAROSCOPIC SCISSORS?

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

Who can help prepare an FDA 510(k) submission like SELECTA-TIP LAPAROSCOPIC SCISSORS?

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.

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
Attributes	Therapeutic

Intended 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)

Related Devices

K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS · Microline Pentax, Inc. · Aug 9, 1996
K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES · Endo-Therapeutics, Inc. · Nov 8, 2001
K970949 — SMITH & NEPHEW MIS INSTRUMENTS · Smith & Nephew Endoscopy, Inc. · Apr 23, 1997
K960554 — DETACHATIP THORACOSCOPIC SCISSORS · Microsurge, Inc. · Mar 5, 1996
K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS · Covidien Lp, Formerly Registered AS United States · Sep 1, 2009

Submission Summary (Full Text)

{0} 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: (508) 922-9810 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. 000007