Disposable Aspiration Needle NA-200H
FDA 510(k) K023272 · The Olympus Optical Co.
510(k) numberK023272
Submission
- Device name
- Disposable Aspiration Needle NA-200H
- Applicant
- The Olympus Optical Co.
Melville, NY, US - Received
- October 1, 2002
- Decision date
- December 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCG – Biopsy Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
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Questions and answers
When was Disposable Aspiration Needle NA-200H cleared by the FDA?
Disposable Aspiration Needle NA-200H (K023272) received a 510(k) decision of Substantially Equivalent on December 23, 2002, 83 days after the submission was received.
What is the product code of K023272?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.