Product code JOL
- Device name
- Catheter And Tip, Suction
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6740
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051370 | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | Baxter Healthcare Corp | 2005-08-12 |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 2001-05-01 |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| K974758 | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974759 | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974397 | STERILE SALINE FOR CATHETER CARE | Baxter Healthcare Corp | 1998-02-10 |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 1998-02-05 |
| K972372 | GERM TRAPPER SUCTION TUBE HOLDER | Rzv Medical Specialties, Inc. | 1997-12-11 |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | 1996-04-15 |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | 1995-12-21 |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Sherwood Medical Co. | 1995-12-15 |
| K951524 | THORACENTESIS CATHETER | Baxter Healthcare Corp | 1995-07-06 |
| K945728 | CATCO THORACIC CATHETER | Catco Medical, Inc. | 1995-05-23 |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | 1995-04-10 |
| K943773 | STERILE WATER | Medline Industries, Inc. | 1995-02-27 |
| K943828 | STERILE WATER FOR IRRIGATION | Orion Life Systems, Inc. | 1994-11-21 |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | Orion Life Systems, Inc. | 1994-11-21 |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Orion Life Systems, Inc. | 1994-11-21 |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | Orion Life Systems, Inc. | 1994-11-21 |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 |
| K932138 | SALINE FOR IRRIGATION | Rantran, Inc. | 1994-11-04 |
| K943833 | STERILE WATER FOR IRRATION | Orion Life Systems, Inc. | 1994-11-01 |
| K931509 | GERITREX STERILE SALINE SOLUTION FOR IRRIGATION | Geritrex Corp. | 1994-09-22 |
| K933762 | STB YANKAUER SUCKER/NOZZLE | Save-T-Breath Distributors C.C. | 1994-07-19 |
| K942061 | DISPOSABLE SUCTION PROBE | United States Surgical, A Division of Tyco Healthc | 1994-05-16 |
| K941232 | THORA-CATH | Gesco Intl., Inc. | 1994-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850088713787 | PRINCETON | Princeton Medical Group, Inc. | 2026-09-22 |
| 00848530109110 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2026-06-10 |
| 00848530107031 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107161 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107154 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107147 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107130 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107123 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107116 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107109 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107093 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107086 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107079 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107062 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107055 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107048 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00848530107024 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2025-08-14 |
| 00860412001572 | SAM Medical | Zien Medical Technologies, LLC | 2024-11-08 |
| 00618029830128 | Q-Care Rx | SAGE PRODUCTS, LLC | 2023-09-07 |
| 00618029830975 | Q-Care | SAGE PRODUCTS, LLC | 2019-07-10 |
| 00618029831149 | Q-Care Rx | SAGE PRODUCTS, LLC | 2018-12-10 |
| 00618029831125 | Q-Care | SAGE PRODUCTS, LLC | 2018-12-10 |
| 00848530086404 | Silicone Suction Tubing Connector 10 grams 4.5in length 2.65mm wall thickness; O | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530061586 | Sunset Healthcare Solutions Suction Tubing - 18" | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00848530060459 | Sunset Healthcare Solutions Suction Tubing - 6ft | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00618029830760 | Q-Care | SAGE PRODUCTS, LLC | 2016-09-24 |
| 00618029830753 | Q-Care | SAGE PRODUCTS, LLC | 2016-09-24 |
| 00618029830173 | Q-Care | SAGE PRODUCTS, LLC | 2016-09-24 |
| 00618029830166 | Q-Care | SAGE PRODUCTS, LLC | 2016-09-24 |
| 00618029830081 | Q-Care | SAGE PRODUCTS, LLC | 2016-09-24 |