Suzhou Acuvu Medical Technology Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 4 device types, 19 products catalogued, 2 clearances.
Suzhou Acuvu Medical Technology Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Forceps, Hysteroscope Accessories and 2 other device types. 19 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3021610866 |
| FEI number | 3021610866 |
| DUNS | 705464292 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park |
| Postal code | 215125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Forceps | Class 1 | Disposable Hysteroscope accessory | 2024 | 99 |
| Hysteroscope (And Accessories) | Class 2 | Disposable Hysteroscope System, HTx Disposable Hysteroscope System, Manual Tissue Removal, Manual Tissue Removal Device | 2021 | 13 |
| Hysteroscope Accessories | Class 1 | eStar – reusable surgical instruments, Hysteroscope accessories | 2022 | 11 |
| Scissors, General, Surgical | Class 1 | Disposable Hysteroscope System | 2024 | 83 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| HTx Disposable Hysteroscope | HIH | 7 |
| Biopsy forceps | HTD | 3 |
| Alligator grasper | HTD | 3 |
| Hook grasper | HTD | 3 |
| Serrated forceps | HTD | 3 |
| Single action scissors | LRW | 3 |
| alligator grasper | NWW | 2 |
| single-action scissors | NWW | 2 |
| hook grasper | NWW | 2 |
| biopsy forceps | NWW | 2 |
| serrated forceps | NWW | 2 |
| Y-type Irrigation Set | NWW | 1 |
| HTx Procedure Pack | NWW | 1 |
| Disposable fluid tube | NWW | 1 |
| Y-type Irrigation Set with 3-way Stopcock | NWW | 1 |
| Omni® Hysteroscopic Grasper | NWW | 1 |
| Portable Image Processor | HIH | 1 |
| HTx Image Processing System | HIH | 1 |
| Disposable Sterile Drape | NWW | 1 |
Clearances
2 clearances name Suzhou Acuvu Medical Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254050 | 2026-05-15 | HIH | Traditional | This company |
| K231260 | 2024-03-05 | HIH | Traditional | This company |
| K211227 | 2021-09-15 | HIH | Traditional | Acuvu, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2017 |
|---|---|
| Main products | Hysteroscopy equipment, Diagnostic hysteroscopy systems, Operative hysteroscopy systems, Hysteroscopy instruments, Electronic endoscope technology |
| Export markets | United States |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.