Clarke-Reich Micro
Laparoscopic Knot Pusher; 6-0 and smaller; 29cm working length
7manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K903560 |
| Record published | 2016-09-21 |
| Record revised | 2024-02-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M4500P | Outer Diameter 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021237 | 2003-04-10 |
| K971836 | 1997-11-07 |
| K971837 | 1997-08-06 |
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.