← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K970563

# OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K970563)

_Olympus America, Inc. · FCG · Apr 11, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K970563

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md)
- **Decision Date:** Apr 11, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Intended Use

The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.

## Device Story

Aspiration needle; used with ultrasound gastroscope for fine needle aspiration (FNA) in gastrointestinal tract; enables tissue sampling under ultrasonic guidance; operated by physicians in clinical settings; provides tissue samples for diagnostic evaluation; facilitates minimally invasive biopsy.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Aspiration needle for use with ultrasound gastroscope; manual operation; biocompatible materials consistent with predicate biopsy instruments.

## Regulatory Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Predicate Devices

- Olympus NA-1C Aspiration Needle ([K904667](/device/K904667.md))

## 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.
>
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K970563
APR 11 1997

# 510 (k) SUMMARY
## OLYMPUS NA-10J-1 ASPIRATION NEEDLE

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

**Device Name:** Olympus NA-10J-1 Aspiration Needle
**Common/Usual Name:** Biopsy Instruments
**Classification Name:** 21 CFR 876.1075
Gastroenterology-Urology Biopsy Instruments
**Predicate Devices:** Olympus NA-1C Aspiration Needle (K904667)
**Prepared & Submitted By:** Mr. Subhash Patel
(Contact Person)
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5481
**Summary Preparation Date:** 02/11/97

### Statement of Intended Use:

The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K970563](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K970563)

**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).

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