Ultravision2 Integrated Monopolar L Hook (H/S)

The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated…

Registry build 21.09.26

The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button.

1manufacturer
1catalogue number
7510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code PQM
Manufacturer City Province Registered as Device types
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44

Record

Regulatory record for Ultravision2 Integrated Monopolar L Hook (H/S)
Listed by Alesi Surgical Ltd, United Kingdom
FDA product code PQM
Device type Surgical Smoke Precipitator
Device class Class 2
Regulation 21 CFR 878.5050
Establishment Specification developer, Manufacturer
510(k) K231298
Record published 2023-12-13

Specifications

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 Carton, inner carton of 5, shipper box of 4

Catalogue Numbers

Catalogue numbers for Ultravision2 Integrated Monopolar L Hook (H/S)
Catalogue number Size Status
DPD-006-201 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
UltravisionTM Alesi Surgical Ltd 11
UltravsionTM Alesi Surgical Ltd 1
Ultravision2 IonPencil Alesi Surgical Ltd 1
Ultravision2 Generator Alesi Surgical Ltd 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K240868 2024-08-12
K231298 2023-10-31
K231238 2023-10-31
K200035 2020-05-04
K182053 2018-09-07
K170178 2017-05-26
DEN150022 2016-12-20

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer