Insufflation NEEDLE,12CM
Insufflation NEEDLE,12CM PN 68017-01M
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin | Tianjin | Manufacturer | 3 |
Record
| Listed by | Ranfac Corp., United States |
|---|---|
| FDA product code | FHO |
| Device type | Pneumoperitoneum Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K930474 |
| Record published | 2017-05-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 16, inner pack of 10 |
| Sizes | Needle gauge 14 G; length 12 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14GA x 12 CM | Needle Gauge 14 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Core Dynamics | ConMed Corporation | 3 |
| Excel | ConMed Corporation | 2 |
| Pneumo-Matic | Coopersurgical, Inc. | 2 |
| Surgineedle | Covidien LP | 2 |
| V. Mueller | Steris Corporation | 2 |
| AccuMedx | Accumedx, LLC | 2 |
| Unimicro | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2 |
| Oneport | ConMed Corporation | 1 |
| Veress Needle | Unimax Medical Systems Inc. | 1 |
| Insufflation NEEDLE,15CM | Ranfac Corp. | 1 |
| THL | Gyrus Acmi, Inc. | 1 |
Showing 12 of 13. All products under Pneumoperitoneum Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K930474 | 1993-07-23 |
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.