No-Scalpel Vasectomy
No-Scalpel Vasectomy Ring Clamp, 3.5mm
5manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Xiamen HOY Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Femcare Ltd., United Kingdom |
|---|---|
| FDA product code | KOA |
| Device type | Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Lumen/inner diameter 3.5 to 4 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Forceps | In distribution | |
| 3.5mm Kit | Lumen/Inner Diameter 3.5 mm | In distribution |
| 3.5mm clamp | Lumen/Inner Diameter 3.5 mm | In distribution |
| 4.0mm kit | Lumen/Inner Diameter 4.0 mm | In distribution |
| 4.0mm Ring Clamp | Lumen/Inner Diameter 4.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 233 |
| Millennium | Avalign Technologies, Inc. | 64 |
| Elmed Incorporated | Elmed, Inc. | 58 |
| Ambler Surgical | Ambler Surgical, LLC | 35 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 33 |
| Cardinal Health | Cardinal Health 200, LLC | 30 |
| Novo Surgical | Novo Surgical, Inc. | 29 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 23 |
| LHB Industries | The Lighthouse For the Blind, Inc. | 15 |
| Zoll-Dental | Zoll-Dental | 13 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 13 |
| Cook | Cook Incorporated | 8 |
Showing 12 of 74. All products under Surgical Instruments, G-U, Manual (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K932465 | 1994-03-02 |
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.