Dolphin II
Dolphin II Transducer Tubing
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | HIG |
| Device type | Insufflator, Hysteroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K011876 |
| Record published | 2016-10-13 |
| Record revised | 2026-04-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Distribution end date | 2026-03-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DOL-TUB | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tube set for irrigation, single-use | W.O.M. World of Medicine GmbH | 9 |
| Insufflator, Hysteroscopic | Karl Storz GmbH & Co. KG | 7 |
| Aquilex Fluid Control System | W.O.M. World of Medicine GmbH | 4 |
| Aveta Smol Disposable Resecting Device, 2.9 mm | Meditrina, Inc. | 4 |
| Tube set for suction, single-use | W.O.M. World of Medicine GmbH | 4 |
| Premier | Premier Dental Products Co. | 3 |
| Fluid Safe | Stryker GmbH | 3 |
| Insufflator, Hysteroscopic | Covidien LP | 3 |
| Hysteroscopic Fluid Management | Smith & Nephew, Inc. | 3 |
| Aveta Disposable Resecting Handset | Meditrina, Inc. | 2 |
| Fluid Monitoring Unit | W.O.M. World of Medicine GmbH | 2 |
| Fluent Fluid Management System | Hologic, Inc. | 2 |
Showing 12 of 58. All products under Insufflator, Hysteroscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110852 | 2011-07-19 |
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.