Colpassist
Vaginal Positioning Device
8manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KOH |
| Device type | Instrument, Manual, General Obstetric-Gynecologic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-10-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0068318210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 33 |
| Z-Clamps | Coopersurgical, Inc. | 30 |
| Quinelato | Schobell Industrial Ltda | 16 |
| Baby Tischler Biopsy Punch Titanium | Medgyn Products, Inc. | 12 |
| Parametrium Clamp | Adeor Medical AG | 12 |
| Baby Tischler Biopsy Punch | Medgyn Products, Inc. | 11 |
| Tischler Biopsy Punch Titanium | Medgyn Products, Inc. | 11 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 11 |
| Sims Malleable Curette | Medgyn Products, Inc. | 10 |
| Tischler Biopsy Punch | Medgyn Products, Inc. | 10 |
| Z-Scissors | Coopersurgical, Inc. | 9 |
| Aesculap | Aesculap AG | 7 |
Showing 12 of 110. All products under Instrument, Manual, General Obstetric-Gynecologic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2021-04-15 | Class II | Packaging process control | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection | 4,549 WW |
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.