Biofill Cannula
Biofill Cannula, Ø=3.8mm, 4 Holes, Rapid, L=15cm, Single-use, Extraction
2manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Human MED AG, Germany |
|---|---|
| FDA product code | QPB |
| Device type | System, Suction, Lipoplasty For Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5040 |
| Establishment | Manufacturer |
| 510(k) | K082025 |
| Record published | 2025-07-30 |
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 | Handling environment temperature 8 to 40 °C; Storage environment temperature 8 to 40 °C |
| Packaging | Cardboard box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STS, Ø=3.5, L=150, 4H, Extraction | In distribution | |
| Single-use, Ø=3.8, L=150, 4H, Extraction | In distribution | |
| Single-use, Ø=3.5, L=150, 4H, Extraction | In distribution | |
| Single-use, Ø=3.8, L=150, 4H, Rapid, Extraction | In distribution | |
| STS, Ø=3.0, L=150, 2H, Extraction | In distribution | |
| STS, Ø=3.8, L=150, 4H, Extraction | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Origins | Solta Medical, Inc. | 164 |
| MicroAire® | Microaire Surgical Instruments LLC | 156 |
| Tulip Gems™ Single-Use | Tulip Medical Products, Inc. | 53 |
| Tulip Gems™ AlphaLuer Single-Use | Tulip Medical Products, Inc. | 33 |
| Vaser | Solta Medical, Inc. | 20 |
| System, Suction, Lipoplasty For Removal | Black & Black Surgical, Inc. | 12 |
| WAL Cannula | Human MED AG | 7 |
| WAL infiltration cannula | Human MED AG | 5 |
| Ayon Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 5 rings | Apyx Medical Corporation | 5 |
| WAL irrigation/aspiration cannula | Human MED AG | 4 |
| Black & Black Surgical, Inc. | Black & Black Surgical, Inc. | 4 |
| Powerx | Solta Medical, Inc. | 3 |
Showing 12 of 66. All products under System, Suction, Lipoplasty For Removal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082025 | 2008-08-13 |
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 |
|---|---|---|---|---|---|---|
| Human MED AG | 510(k) number | 2024-10-18 | Class II | Process control | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. | 775 devices |
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.