Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1720](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1720) → OKX — Trocar Kit

# OKX · Trocar Kit

_Obstetrics/Gynecology · 21 CFR 884.1720 · Class 2_

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

## Overview

- **Product Code:** OKX
- **Device Name:** Trocar Kit
- **Regulation:** [21 CFR 884.1720](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1720)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

(1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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