Abbi
The filing names ABBI as the Air Bubble Based Infuser and describes it as a dual barrel syringe connected to an intrauterine catheter to instill saline air contrast during SonoHSG. It also…
The filing names ABBI as the Air Bubble Based Infuser and describes it as a dual barrel syringe connected to an intrauterine catheter to instill saline air contrast during SonoHSG.
It also describes saline infusion through an intrauterine catheter for saline infusion sonography, abbreviated SIS.
Listed Item
ABBI™ KIT (Air Bubble Based Infuser) For office based Sono HSG Procedures
Stated Procedures
For SonoHSG, the stated use is a continuous stream of alternating saline and air contrast media into the uterus and fallopian tubes with an intrauterine catheter. For SIS, saline is instilled into the uterus as a continuous stream.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K143415 |
| Record published | 2016-09-06 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ABBI-KIT | In distribution | |
| ABBI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 39 |
| Cannula, Manipulator/Injector, Uterine | C R I | 31 |
| Marina Medical | Marina Medical Instruments, Inc. | 29 |
| HSG Catheter | Titus Medical LLC | 26 |
| HNM Women Care | HNM Stainless, LLC. | 20 |
| Bioteque | Bioteque Taiwan Ltd. | 16 |
| Viky | Endocontrol | 15 |
| Cannula, Manipulator/Injector, Uterine | Panpac Medical Corporation | 14 |
| Uterine ElevatOR Pro | THE O R Company PTY Ltd | 12 |
| Valtchev Uterine Mobilizer | Conkin Surgical Instruments Ltd. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| McCarus-Volker Fornisee® System | LSI Solutions Inc. | 9 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223064 | 2022-10-28 |
| K153092 | 2015-12-21 |
| K143415 | 2015-02-26 |
| K141523 | 2014-11-25 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-03-31 | Class II | Component design/selection | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | 169 units | |
| 2022-03-31 | Class II | Component design/selection | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | 73 units | |
| 2022-03-31 | Class II | Component design/selection | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | 90 units | |
| 2015-05-18 | Class II | Device Design | Design of device may expose user to injury to fingers or body parts | 5 units | 2015-08-07 |
| 2014-07-03 | Class II | Packaging process control | Unsealed pouches. | 1,400 units | 2015-05-28 |
| 2014-05-13 | Class II | Process control | Sterility of the device may be compromised due to unsealed pouch | 1180 units | 2015-05-28 |
| 2012-10-31 | Class II | Device Design | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle | 1215 total | 2014-03-04 |
| 2012-10-31 | Class II | Device Design | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle | 1215 total | 2014-03-04 |
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.