Surgigraphic
The SurgicGraphic 6000 Surgical Table is primarily designed for minimally invasive endovascular, vascular, cardiovascular, pain management, and other procedures requiring intra-operative…
The SurgicGraphic 6000 Surgical Table is primarily designed for minimally invasive endovascular, vascular, cardiovascular, pain management, and other procedures requiring intra-operative fluoroscopic C-Arm imaging.
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (5), Hebei (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
Showing 12 of 29. All 29 manufacturers in China registered for Table, Operating-Room, Electrical
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | GDC |
| Device type | Table, Operating-Room, Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2025-01-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Surgigraphic 6000 Table | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 115 |
| Nuvo | Medical Illumination International, Inc | 94 |
| Operon | Berchtold Gmbh & Co. KG | 85 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 58 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 53 |
| Medstone | Stille AB | 41 |
| imagiQ | Stille AB | 37 |
| Leg Traction Device | Mizuho Corporation | 35 |
| Radiographic Tops Fixed Type | Mizuho Corporation | 33 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 28 |
| Operating Table MOT-VS500 | Mizuho Corporation | 24 |
| Allen | Hill-ROM, Inc. | 22 |
Showing 12 of 273. All products under Table, Operating-Room, Electrical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971390 | 1997-05-15 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-10 | Class II | Device Design | The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shr | 999 | 2015-06-26 |
| 2012-04-06 | Class II | Device Design | STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if | 379 tables | 2013-09-04 |
| 2009-04-17 | Not classified | Device Design | Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface. | 412 units | 2012-03-01 |
| 2007-02-06 | Not classified | Other | A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff. | 46 tables | 2009-09-11 |
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.