Insufflator, Hysteroscopic

Hysteroscopic Outflow Tube Set

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HIG
Manufacturer City Province Registered as Device types
Peter’s Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Record

Regulatory record for Insufflator, Hysteroscopic
Listed by Covidien LP, United States
FDA product code HIG
Device type Insufflator, Hysteroscopic
Device class Class 2
Regulation 21 CFR 884.1700
510(k) K031616
Record published 2018-08-31
Record revised 2025-06-24 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment humidity 20 to 90 % RH; Storage environment temperature -4 to 140 °F
Packaging Pallet of 8, case of 6, pack_or_inner_pack of 5
Distribution end date 2026-03-03

Catalogue Numbers

Catalogue numbers for Insufflator, Hysteroscopic
Catalogue number Size Per pack Status
72200869 2 In distribution
7209823 In distribution
7209822 Withdrawn

Same Product Code

Other products under the same FDA 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
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
Conmed ConMed Corporation 2

Showing 12 of 58. All products under Insufflator, Hysteroscopic

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