Single Use Aspiration Needle NA-220H/230H
8 catalogue numbers from NA-220H-8019, listed by Olympus Medical Systems Corp., Japan, under Biopsy Needle. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
8catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K023272 |
| Record published | 2016-09-21 |
| Record revised | 2022-06-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Distribution end date | 2022-06-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA-220H-8019 | Withdrawn | |
| NA-220H-8022 | Withdrawn | |
| NA-220H-8019 | Withdrawn | |
| NA-230H-8022 | Withdrawn | |
| NA-230H-8022 | Withdrawn | |
| NA-220H-8025 | Withdrawn | |
| NA-220H-8022 | Withdrawn | |
| NA-220H-8025 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252646 | 2025-10-24 |
| K180668 | 2018-11-15 |
| K181994 | 2018-10-31 |
| K180449 | 2018-06-08 |
| K160098 | 2016-03-22 |
| K151738 | 2015-11-20 |
| K050503 | 2005-05-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (globally); 260,395 (US) | 2024-03-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.