Who is the manufacturer of INTERCEPTRE LAPAROSCOPIC INSTRUMENTS?

Smith & Nephew, Inc. filed the 510(k) submission for INTERCEPTRE LAPAROSCOPIC INSTRUMENTS (K970151).

What is the FDA product code for INTERCEPTRE LAPAROSCOPIC INSTRUMENTS?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for INTERCEPTRE LAPAROSCOPIC INSTRUMENTS?

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

Who can help prepare an FDA 510(k) submission like INTERCEPTRE 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.

INTERCEPTRE LAPAROSCOPIC INSTRUMENTS

Q: What are the predicate devices for INTERCEPTRE LAPAROSCOPIC INSTRUMENTS?

Karl Storz Take-Apart Endoscopic Instruments; Richard Wolf Laparoscopic Instruments; Smith and Nephew Endoscopic Instruments.

K970151 · Smith & Nephew, Inc. · HET · Mar 18, 1997 · Obstetrics/Gynecology

Device Facts

Record ID	K970151
Device Name	INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
Applicant	Smith & Nephew, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Mar 18, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.

Device Story

Interceptre™ Endoscopic Instruments; line of hand-held, reusable, non-sterile surgical instruments including graspers, dissectors, and scissors. Used in laparoscopic procedures to grasp, manipulate, cut, and cauterize soft tissue. Operated by surgeons in clinical/OR settings. Mechanical design facilitates tissue interaction; electrosurgical components enable cauterization. Benefit: minimally invasive tissue management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Hand-held, reusable, non-sterile endoscopic instruments. Includes graspers, dissectors, and scissors. Electrosurgical capability for tissue cauterization. Mechanical actuation.

Indications for Use

Indicated for grasping, manipulating, cutting, and cauterizing soft tissue during laparoscopic surgical procedures.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

Karl Storz Take-Apart Endoscopic Instruments
Richard Wolf Laparoscopic Instruments
Smith and Nephew Endoscopic Instruments

Related Devices

K974592 — INTERCEPTRE LAPAROSCOPIC INSTRUMENTS · Smith & Nephew, Inc. · Jan 12, 1998
K140101 — ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS · Ab Medica Sas · Jul 10, 2014
K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES · Endo-Therapeutics, Inc. · Nov 8, 2001
K171825 — Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Feb 13, 2018
K101733 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES · Sac, LLC Dba Pinnacle Medical Surgical · Jun 6, 2011

Submission Summary (Full Text)

{0} K970151 MAR 18 1997 # Section 7- 510k Summary of Safety and Effectiveness | 7.1 Statement | This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 | | --- | --- | | 7.2 Submitter | Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, Ma. 02048 | | 7.3 Company Contact | Susan Finneran Clinical/ Regulatory Affairs (508) 261-3772 | | 7.4 Device Name | Proprietary Name: Interceptre™ Laparoscopic Instruments Common Name: Minimally Invasive Surgical Instruments: graspers, dissectors, scissors, Classification Name: Endoscopic accessories(78 GCJ) Laparoscopic accessories (85 HET) Electrosurgical accessories (79 BWA, 78 KNS) | | 7.5 Predicate Legally Marketed Devices | • Karl Storz Take-Apart Endoscopic Instruments • Richard Wolf Laparoscopic Instruments • Smith and Nephew Endoscopic Instruments | | 7.6 Device Description | The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile, reusable instruments | | 7.7 Intended Use | The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue. |