Who is the manufacturer of OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K970563).

What is the FDA product code for OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

FCG. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

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

Who can help prepare an FDA 510(k) submission like OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

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.

OLYMPUS NA-10J-1 ASPIRATION NEEDLE

Q: What are the predicate devices for OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

Olympus NA-1C Aspiration Needle (K904667).

K970563 · Olympus America, Inc. · FCG · Apr 11, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K970563
Device Name	OLYMPUS NA-10J-1 ASPIRATION NEEDLE
Applicant	Olympus America, Inc.
Product Code	FCG · Gastroenterology, Urology
Decision Date	Apr 11, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

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.

Indications for Use

Indicated for fine needle aspiration (FNA) within the gastrointestinal tract under ultrasonic guidance using the Olympus GF-UM30P ultrasound gastroscope.

Regulatory Classification

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)

Related Devices

K151738 — Single Use Aspiration Needle NA-U200H · Olympus Medical Systems Corp. · Nov 20, 2015
K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE · Olympus America, Inc. · Nov 18, 1997
K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM · Medi-Globe Corp. · Mar 31, 1999
K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM · Medi-Globe Corporation · May 8, 2009
K181994 — Single Use Aspiration Needle NA-U201H · Olympus Medical Systems Corp. · Oct 31, 2018

Submission Summary (Full Text)

{0} 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. 24