Hangzhou Kangji Medical Instrument Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 27 device types, 3 clearances.
Hangzhou Kangji Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Retractor and 25 other device types. Its earliest product listing with the FDA dates from 2012.
27device types registered with the FDA
3510(k) clearances
Registration
| Registered name | HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008843439 |
| FEI number | 3008843439 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州康基医疗器械有限公司 |
|---|---|
| Unified social credit code | 913301227654669888 |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No. 1668 Chunjiang East Rd |
| Postal code | 311501 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applier, Hemostatic Clip | Class 1 | Clip Applier | 2012 | 6 |
| Cannula And Trocar, Suprapubic, Non-Disposable | Class 1 | Trocar and Cannula | 2012 | 2 |
| Cannula, Surgical, General & Plastic Surgery | Class 1 | Trocar and Cannula | 2012 | 14 |
| Clamp, Uterine | Class 1 | uterine manipulator set, re-usable | 2015 | 4 |
| Clip, Implantable | Class 2 | Dannik Titanium Ligation Clip, K-Clip | 2020 | 4 |
| Container, Specimen, Sterile | Class 1 | Specimen Bag, Specimen Retrieval Bag | 2012 | 79 |
| Dissector, Surgical, General & Plastic Surgery | Class 1 | Grasper, Biopsy Forceps | 2012 | 14 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | DANNIK Disposable Monopolar Laparoscopic Instrument | 2024 | 65 |
| Forceps | Class 1 | surgical forceps | 2014 | 99 |
| Forceps, Biopsy, Gynecological | Class 1 | Biopsy Forceps | 2012 | 11 |
| Forceps, Biopsy, Non-Electric | Class 1 | Urology Biopsy | 2014 | 44 |
| Forceps, Wire Closure, Ent, Non-Sterile | Class 1 | Closure Forceps | 2013 | 1 |
| Holder, Needle, Gastroenterologic | Class 1 | Needle Holder | 2012 | 8 |
| Instrument, Clip Removal | Class 1 | Clip Remover | 2024 | 5 |
| Instrument, Cutting, Orthopedic | Class 1 | Instrument for Cutting | 2013 | 11 |
| Instrument, Ent Manual Surgical | Class 1 | Instruments for E.N.T. Mamual Surgical | 2013 | 11 |
| Instrument, Ligature Passing And Knot Tying | Class 1 | Knot pusher | 2013 | 8 |
| Instrument, Manual, General Obstetric-Gynecologic | Class 1 | Uterine Manipulator | 2024 | 8 |
| Instrument, Manual, Surgical, General Use | Class 1 | VAT Instruments, Palpation Probe, Hypodermic Syringe, Suction& Irrigation, Guiding Bar | 2024 | 110 |
| Insufflator, Laparoscopic | Class 2 | Disposable Veress Needles | 2024 | 10 |
| Knife, Surgical | Class 1 | Bile Duct Scalpel | 2024 | 8 |
| Laparoscope, General & Plastic Surgery | Class 2 | AEON Retrieval Bag, Disposable Trocars, DANNIK Laparoscopic Suction Irrigation System | 2018 | 46 |
| Needle, Aspiration And Injection, Reusable | Class 1 | Aspir Needle, Veress Needle | 2012 | 7 |
| Pneumoperitoneum Needle | Class 2 | Disposable Veress Needles | 2024 | 4 |
| Retractor | Class 1 | Retractor | 2012 | 34 |
| Scissors, General, Surgical | Class 1 | scissor | 2012 | 83 |
| Tray, Surgical, Instrument | Class 1 | Reuseble sterilization case, Tray for Surgical Instruments | 2013 | 105 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250643 | 2025-11-20 | FZP | Traditional | This company |
| K233263 | 2024-04-09 | GCJ | Traditional | This company |
| K232401 | 2023-12-14 | HIF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | microwave ablation system, bipolar high-frequency ultrasound fusion system, disposable ligation clips, electronic uterine resector, disposable electrosurgical instruments |
|---|
Nearby Manufacturers
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.
The manufacturer named here can complete this record.