Irrisept
Clinical Research Wound Debridment and Cleansing System
17manufacturers in China registered for this device type
5catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (7), Beijing (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Shenzhen Relish Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Showing 12 of 17. All 17 manufacturers in China registered for Lavage, Jet
Record
| Listed by | Irrimax Corporation, United States |
|---|---|
| FDA product code | FQH |
| Device type | Lavage, Jet |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5475 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-02-12 |
| Record revised | 2022-12-20 (version 7) |
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 |
| Storage | Storage environment temperature 10 to 30 °C |
| Sizes | Total volume 450 ml |
| Distribution end date | 2022-10-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ISEPT-500-CAN | Total Volume 450 ml | 12 | Withdrawn |
| APP-001 | 21 | Withdrawn | |
| ISEPT-450-STU | Total Volume 450 ml | 12 | Withdrawn |
| CT-901 | Total Volume 450 ml | 6 | Withdrawn |
| Irrisept-403 | Total Volume 450 ml | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 65 |
| InterPulse | Stryker GmbH | 41 |
| Lavage, Jet | Stryker GmbH | 40 |
| Pulsavac® | Zimmer Orthopaedic Surgical Products | 35 |
| MicroAire® | Microaire Surgical Instruments LLC | 34 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 32 |
| Simpulse | Davol Inc. | 31 |
| AWI | Apex (Suzhou) Medical Products Company | 27 |
| CarboJet® CO2 Bone Lavage System | Kinamed, Inc. | 26 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 20 |
| Erbe | Erbe Elektromedizin GmbH | 18 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 18 |
Showing 12 of 98. All products under Lavage, Jet
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222804 | 2022-09-22 |
| K210536 | 2021-05-28 |
| K202222 | 2020-12-14 |
| K080779 | 2009-02-04 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-08-16 | Class II | Process control | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | 1,031 cases (12,372 units) | 2020-09-25 |
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.