FMS
FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)
21manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
5recalls on this code
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K954465 |
| Record published | 2016-10-12 |
| Record revised | 2026-03-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Pallet 2 Stacked; Special storage condition: Keep Dry; Handling environment temperature 5 to 49 °C; Storage environment temperature 41 to 120 °F; Handling environment temperature 41 to 120 °F; Storage environment temperature 5 to 49 °C |
| Packaging | Package of 5, package of 24, box of 12 |
| Distribution end date | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 287505 | In distribution | |
| 287305 | In distribution | |
| 287865 | In distribution | |
| 287869 | In distribution | |
| 284510 | In distribution | |
| 287535 | In distribution | |
| 287745 | In distribution | |
| 218027 | In distribution | |
| 287735 | In distribution | |
| 281583 | In distribution | |
| 287875 | In distribution | |
| 287427 | In distribution | |
| 287345 | In distribution | |
| 284504 | In distribution | |
| 284549 | In distribution | |
| 288022 | In distribution | |
| 282112 | In distribution | |
| 287315 | In distribution | |
| 287775 | In distribution | |
| 287375 | In distribution | |
| 284172 | Withdrawn | |
| 282000 | Withdrawn | |
| 284171 | Withdrawn | |
| 284176 | Withdrawn | |
| 288051 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233675 | 2024-02-26 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| DePuy Mitek, Inc. | 510(k) number | 2015-11-20 | Class II | Process control | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | 50 units | 2017-04-12 |
| DePuy Mitek, Inc. | 510(k) number | 2015-11-20 | Class II | Process control | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | 45 units | 2017-04-12 |
| DePuy Mitek, Inc. | 510(k) number | 2015-11-20 | Class II | Process control | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | 115 units | 2017-04-12 |
| DePuy Mitek, Inc. | 510(k) number | 2013-08-29 | Class II | Component change control | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-conta | 368 pk | 2016-05-12 |
| DePuy Mitek, Inc. | 510(k) number | 2013-08-29 | Class II | Component change control | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-conta | 29280 units | 2016-05-12 |
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.