Laparoscope, Gynecologic (And Accessories)
Operating Sheath, straight, size 5.6 Fr.
7manufacturers in China registered for this device type
119catalogue numbers in this listing
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 | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Record published | 2016-09-23 |
| Record revised | 2024-10-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 26182D | In distribution | ||
| 26173FP | In distribution | ||
| 26178P | In distribution | ||
| 26479F | In distribution | ||
| 26163DO | In distribution | ||
| 30141AA | In distribution | ||
| 50251MS | In distribution | ||
| 26173HSV | In distribution | ||
| 26175BK | In distribution | ||
| 11540OS | In distribution | ||
| 26153EA | In distribution | ||
| 26330040 | In distribution | ||
| 28164NBB | In distribution | ||
| 26175BA | In distribution | ||
| 11540FGR | In distribution | ||
| 26173T | In distribution | ||
| 11650TI | 2 | In distribution | |
| 26175NL | In distribution | ||
| 30140GE | In distribution | ||
| 26183RC | In distribution | ||
| 11650TH | 2 | In distribution | |
| 26167HH | In distribution | ||
| 30142HB | In distribution | ||
| 26167TNL | In distribution | ||
| 26163CS | In distribution | ||
| 26188FL | In distribution | ||
| 26183RA | In distribution | ||
| 26175B | In distribution | ||
| 26167HA | In distribution | ||
| 26161VB | In distribution | ||
| 11605KC | In distribution | ||
| 26167T | In distribution | ||
| 26175CK | In distribution | ||
| 50251LCS | In distribution | ||
| 30140FB | In distribution | ||
| 11506AA | In distribution | ||
| 11650TF | In distribution | ||
| 30140GB | In distribution | ||
| 30140KA | In distribution | ||
| 30140BA | In distribution | ||
| 26175P | In distribution | ||
| 26183DA | In distribution | ||
| 26020HM | In distribution | ||
| 26188SA | In distribution | ||
| 26182TA | In distribution | ||
| 26175TT | In distribution | ||
| 11650TD | 2 | In distribution | |
| 26175BL | In distribution | ||
| 11510KA | 2 | In distribution | |
| 26159HS | In distribution | ||
| 11521A | In distribution | ||
| 26020HP | In distribution | ||
| 26022MA | In distribution | ||
| 11515AA | In distribution | ||
| 26188FA | In distribution | ||
| 11510C | In distribution | ||
| 11605KCO | In distribution | ||
| 26020HL | In distribution | ||
| 11510KE | 2 | In distribution | |
| 30141HE | In distribution | ||
| 11650TG | 2 | In distribution | |
| 26020OE | In distribution | ||
| 11521SL | In distribution | ||
| 26175NL | In distribution | ||
| 30140EB | In distribution | ||
| 26182TB | In distribution | ||
| 26093CD | In distribution | ||
| 26182TC | In distribution | ||
| 11540KD | 6 | In distribution | |
| 20300047 | In distribution | ||
| 26175NS | In distribution | ||
| 26167TL | In distribution | ||
| 28164NBC | In distribution | ||
| 26173HSK | In distribution | ||
| 26040OC | In distribution | ||
| 11650R | In distribution | ||
| 30140DA | In distribution | ||
| 30140CB | In distribution | ||
| 26175NS | In distribution | ||
| 11540HM | In distribution | ||
| 26175NE | In distribution | ||
| 26785RLL | In distribution | ||
| 26031SO | 2 | In distribution | |
| 11650L | In distribution | ||
| 26178R | In distribution | ||
| 26178T | In distribution | ||
| 11510KD | 2 | In distribution | |
| 11565 | In distribution | ||
| 30140FE | In distribution | ||
| 11522SL | In distribution | ||
| 26175NE | In distribution | ||
| 30140DD | In distribution | ||
| 26183BD | In distribution | ||
| 30141DB | In distribution | ||
| 26175T | In distribution | ||
| 26175PD | In distribution | ||
| 30140DB | In distribution | ||
| 26330041 | In distribution | ||
| 11510KC | 6 | In distribution | |
| 26055CO | In distribution | ||
| 30141HB | In distribution | ||
| 30140GD | In distribution | ||
| 20014430 | In distribution | ||
| 26182TAA | 6 | In distribution | |
| 11540KLS | In distribution | ||
| 26161VS | In distribution | ||
| 11540FGE | 5 | In distribution | |
| 26175R | In distribution | ||
| 30140HB | In distribution | ||
| 26020OM | In distribution | ||
| 26055BE | In distribution | ||
| 26183DB | In distribution | ||
| 30140EE | In distribution | ||
| 26182TG | In distribution | ||
| 26167TS | In distribution | ||
| 30140HE | In distribution | ||
| 26188FT | In distribution | ||
| 11522S | In distribution | ||
| 26182TH | 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 |
| 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 |
| Olmypus | Olympus Winter & IBE Gmbh | 23 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-02-27 | Class II | Under Investigation by firm | Inadequate reprocessing validation evidence | 27 units |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2023-10-24 | Class II | Device Design | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. | 1,127 |
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.