Heartline Debakey Grasper
Heartline Debakey Grasper 2.8 x 15 Millimeter Jaw Squeeze Handle
46manufacturers in China registered for this device type
42catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Comhuge Medical Wire AND Harness Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Repacker / relabeller |
| 510(k) | K152400 |
| Record published | 2016-08-19 |
| Record revised | 2018-09-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 18.3 to 31.2 cm |
| Distribution end date | 2018-09-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2800-7823 | 5mm Diameter Shaft | In distribution |
| 2800-7821S | 5mm Diameter Shaft | In distribution |
| 2800-340L | Shaft Diameter 5.0 Millimeter | In distribution |
| 2800-7820L | 5mm Diameter Shaft | In distribution |
| 2800-341 | 5mm Diameter Shaft | In distribution |
| 2800-7820S | 5mm Diameter Shaft | In distribution |
| 2800-7819L | Tube Shaft Outer Diameter 5.0 Millimeter | In distribution |
| 2800-7827 | 3mm Diameter Shaft | In distribution |
| 2800-7822 | 1.5x15mm Jaw | In distribution |
| 2800-7824S | Length 26.2 cm | In distribution |
| 2800-340 | 5mm Diameter Shaft | In distribution |
| 2800-7821 | 5mm Diameter Shaft | In distribution |
| 2800-7824 | Length 26.2 cm | In distribution |
| 2800-7820 | 5mm Diameter Shaft | In distribution |
| 2800-341S | 5mm Diameter Shaft | In distribution |
| 2800-340S | 5mm Diameter Shaft | In distribution |
| 2800-7823S | Length 19.1 cm | In distribution |
| 2800-7822L | Tube Shaft Outer Diameter 5.0 Millimeter | In distribution |
| 2800-7822S | Length 18.5 cm | Withdrawn |
| 2800-340 | Length 23.8 cm | Withdrawn |
| 2800-341S | Length 18.6 cm | Withdrawn |
| 2800-7820S | Length 18.3 cm | Withdrawn |
| 2800-341 | Length 24.1 cm | Withdrawn |
| 2800-7823L | Length 29.6 cm | Withdrawn |
| 2800-7824L | Length 31.2 cm | Withdrawn |
| 2800-7821S | Length 18.5 cm | Withdrawn |
| 2800-7820L | 1.7x11mm Jaw | Withdrawn |
| 2800-7824 | 1.5x23mm Jaw | Withdrawn |
| 2800-7822 | Length 24 cm | Withdrawn |
| 2800-7823 | 1.5x23mm Jaw | Withdrawn |
| 2800-7823S | Length 19.1 cm | Withdrawn |
| 2800-7827 | Length 25.4 cm | Withdrawn |
| 2800-7821L | 1.5x15mm Jaw | Withdrawn |
| 2800-7827S | Length 19.9 cm | Withdrawn |
| 2800-340S | Length 18.3 cm | Withdrawn |
| 2800-7827L | Length 30.4 cm | Withdrawn |
| 2800-7821 | 1.5x15mm Jaw | Withdrawn |
| 2800-7820 | Length 23.8 cm | Withdrawn |
| 2800-341L | Length 29.1 cm | Withdrawn |
| 2800-340L | 5mm Diameter Shaft | Withdrawn |
| 2800-7822L | Length 29 cm | Withdrawn |
| 2800-7824S | 1X2 Jaw | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 3,796 |
| Surgical Direct | Surgical Direct, Inc. | 2,319 |
| Novo Surgical | Novo Surgical, Inc. | 1,320 |
| Elmed Incorporated | Elmed, Inc. | 911 |
| Laparoscope, General & Plastic Surgery | Karl Storz GmbH & Co. KG | 774 |
| Snowden-Pencer | Steris Corporation | 693 |
| Millennium | Avalign Technologies, Inc. | 683 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 615 |
| Clickline | Karl Storz GmbH & Co. KG | 582 |
| V. Mueller | Carefusion 2200, Inc. | 553 |
| Grasping forceps | Sopro-Comeg GmbH | 462 |
| Gimmi | Gimmi Gmbh | 387 |
Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152400 | 2016-01-22 |
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.