(57 days)
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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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 876.1075Gastroenterology-Urology Biopsy Instruments |
| Predicate Devices: | Olympus NA-1C Aspiration Needle (K904667) |
| Prepared & Submitted By: Mr. Subhash Patel(Contact Person) | Olympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, 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.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.