Panels › General, Plastic Surgery › Product code GBX · Class 1
Catheter, Irrigation
Regulation 878.4200
0510(k)s in 12 months (77 all time)
7recalls in 12 months (83 all time)
3recalls that name a 510(k)
Top companies in GBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 53 |
| Degania Silicone, Ltd. | 0 | 10 |
| Rocket Medical Plc | 0 | 6 |
| Navarre Biomedical , Ltd. | 5 | 0 |
| Sil-Med Corp. | 5 | 0 |
| Axiom Medical, Inc. | 3 | 0 |
| Hospira Inc. | 0 | 3 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 3 | 0 |
| Mikro-Tek Laboratories | 3 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-20-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-16-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-18-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with f Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-18-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fene Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-12-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with f Open, Classified |
GBX | None listed |
| Dec 18, 2025 | Rocket Medical Plc Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-12-PK
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium Open, Classified |
GBX | None listed |
| May 1, 2024 | Cardinal Health 200, LLC Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 Open, Classified |
GBX | None listed |
| May 1, 2024 | Cardinal Health 200, LLC Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601 Open, Classified |
GBX | None listed |
| May 1, 2024 | Cardinal Health 200, LLC Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D Open, Classified |
GBX | None listed |
| May 1, 2024 | Cardinal Health 200, LLC Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D Open, Classified |
GBX | None listed |
| May 1, 2024 | Cardinal Health 200, LLC Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D Open, Classified |
GBX | None listed |
| Jan 19, 2023 | Maquet Cardiovascular, LLC Vasoshield Syringe Packs, Model VH-5001 Open, Classified |
GBX | K082725 |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 Open, Classified |
GBX | None listed |
| Jan 18, 2023 | Cardinal Health 200, LLC Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 Open, Classified |
GBX | None listed |
| Aug 31, 2021 | Centese Inc. Thoraguard Chest Tube Kit, 20 Fr Terminated |
GBX | None listed |
| Feb 12, 2021 | TELEFLEX MEDICAL INC PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thora Terminated |
GBX | None listed |
| Aug 7, 2020 | TELEFLEX MEDICAL INC Pleur-evac Thoracic Catheters
Catalog No: DTRC-20S
The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is in Terminated |
GBX | None listed |
| Mar 6, 2020 | Cook Inc. Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643 Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain
PN: 02872
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to in Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Medline Silicone Drain 15Fr 3/16" Full Fluted
PN: DYNJWE2188HB
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fl Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar
Cardinal Health: PN JP-2225
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inten Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar
Cardinal Health: PN: JP-2191
An introduction/drainage catheter is a device that is a flexible single or multilumen tube inte Terminated |
GBX | None listed |
| Jun 28, 2019 | Degania Silicone, Ltd. Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes
Cardinal Health: PN JP-2190
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be use Terminated |
GBX | None listed |
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