← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K970151

# INTERCEPTRE LAPAROSCOPIC INSTRUMENTS (K970151)

_Smith & Nephew, Inc. · HET · Mar 18, 1997 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K970151

## Device Facts

- **Applicant:** Smith & Nephew, Inc.
- **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md)
- **Decision Date:** Mar 18, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1720
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **Attributes:** Therapeutic

## Indications for 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.

## Regulatory 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

## 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}

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.  |

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K970151](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K970151)

**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