FDA Product Code
FDA Product Code JOL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6740
510(k) Clearances — 84 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051370 | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | Baxter Healthcare Corp | 2005-08-12 | Traditional | PDF ↗ |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 | Traditional | PDF ↗ |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 | Traditional | PDF ↗ |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 2001-05-01 | Traditional | PDF ↗ |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K974759 | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 | Traditional | PDF ↗ |
| K974758 | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 | Traditional | PDF ↗ |
| K974397 | STERILE SALINE FOR CATHETER CARE | Baxter Healthcare Corp | 1998-02-10 | Traditional | PDF ↗ |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K972372 | GERM TRAPPER SUCTION TUBE HOLDER | Rzv Medical Specialties, Inc. | 1997-12-11 | Traditional | PDF ↗ |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | 1996-04-15 | Traditional | PDF ↗ |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Sherwood Medical Co. | 1995-12-15 | Traditional | PDF ↗ |
| K951524 | THORACENTESIS CATHETER | Baxter Healthcare Corp | 1995-07-06 | Traditional | PDF ↗ |
| K945728 | CATCO THORACIC CATHETER | Catco Medical, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K943773 | STERILE WATER | Medline Industries, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943828 | STERILE WATER FOR IRRIGATION | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | Orion Life Systems, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K932138 | SALINE FOR IRRIGATION | Rantran, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K943833 | STERILE WATER FOR IRRATION | Orion Life Systems, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K931509 | GERITREX STERILE SALINE SOLUTION FOR IRRIGATION | Geritrex Corp. | 1994-09-22 | Traditional | PDF ↗ |
| K933762 | STB YANKAUER SUCKER/NOZZLE | Save-T-Breath Distributors C.C. | 1994-07-19 | Traditional | PDF ↗ |
| K942061 | DISPOSABLE SUCTION PROBE | United States Surgical, A Division of Tyco Healthc | 1994-05-16 | Traditional | PDF ↗ |
| K941232 | THORA-CATH | Gesco Intl., Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K933526 | STERILE WATER | Trinity Laboratories, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K931511 | GERITREX STERILE WATER FOR IRRIGATION | Geritrex Corp. | 1994-02-14 | Traditional | PDF ↗ |
| K934382 | VCI SUCTION/IRRIGATION TUBING SET | Vital Concepts, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K932185 | SURGICAL SUCTION TIP | Tlc Medservices, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K922714 | UNIVERSAL IRRIGATION & SUCTION TUBING SET | Ximed Medical Systems | 1993-08-03 | Traditional | PDF ↗ |
| K913896 | JAIN BLOOD SHIELD | Jain Surgical Equipment, Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K913876 | ENDOTRACHEAL SUCTIONTUBE | Willowtech | 1992-03-06 | Traditional | PDF ↗ |
| K910693 | PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET | Baxter Healthcare Corp | 1991-10-17 | Traditional | PDF ↗ |
| K910963 | THOROCENTESIS KIT | Megadyne Medical Products, Inc. | 1991-06-20 | Traditional | PDF ↗ |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | Superior Healthcare Group, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K903569 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | 1990-09-07 | Traditional | PDF ↗ |
| K890039 | KLEEN TEST BASIN SET | Kleen Test Products | 1989-10-24 | Traditional | PDF ↗ |
| K893667 | SUCTION TIP | Thomson & Shelton Instrumentation Co, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K893527 | LAPAROSCOPIC SUCTION PROBE | Dexide, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K893135 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER | Premium Plastics, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K883905 | ARROW PNEUMOTHORAX KIT, AK-01500 | Arrow Intl., Inc. | 1989-01-19 | Traditional | PDF ↗ |
| K872948 | URESIL THORA-FLO THORACENTESIS PROCEDURE KIT | Uresil Corp. | 1987-11-27 | Traditional | PDF ↗ |
| K873464 | VAN DELLEN CANNULA | Van Dellen, Ltd. | 1987-11-23 | Traditional | PDF ↗ |
| K873563 | APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY | Aplicare, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K873517 | DEKNATEL THORACIC CATHETER | Deknatel, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K873525 | DEKNATEL TROCAR CATHETER | Deknatel, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K871950 | VIA-GUARD | Surgimark, Inc. | 1987-07-23 | Traditional | PDF ↗ |
| K870572 | ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT | Arrow Intl., Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K864937 | 'EXMOOR' ZOELLNER SUCKER ENDS | Exmoor Plastics , Ltd. | 1987-03-30 | Traditional | PDF ↗ |
| K860927 | HD CRYSTALINE SUCTION TIP | Hospital Disposables, Inc. | 1986-03-27 | Traditional | PDF ↗ |
| K852041 | DEKNATEL THORACIC CATHETER | Pfizer, Inc. | 1985-06-17 | Traditional | PDF ↗ |
| K851979 | TROCAR CATHETER | Hospital Products Group | 1985-06-17 | Traditional | PDF ↗ |
| K851611 | IMPACT TURBO CATH | Impact Instrumentation, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K851385 | THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE | Gesco Intl., Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K850240 | KM PRODUCTS SUCTION TIPS | Km Products | 1985-03-06 | Traditional | PDF ↗ |
| K843469 | PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- | Zimmar Consulting , Ltd. | 1984-11-19 | Traditional | PDF ↗ |
| K843188 | WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP | Wells Johnson Co. | 1984-09-20 | Traditional | PDF ↗ |
| K840669 | SUCTION DEVICE-PHARYNEAL DEVICE | Lipsky-Dale Medical Products | 1984-06-11 | Traditional | PDF ↗ |
| K840007 | SURGICAL SUCTION INSTRUMENT-REUSABLE | Lawton Surgical Instruments | 1984-03-06 | Traditional | PDF ↗ |
| K832880 | TRACHEOSTOMY CARE TRAYS | Packaging Technologies, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832517 | CUSTOM KWIK SET AND/OR PAK | Norton Texas Medical Products | 1983-10-14 | Traditional | PDF ↗ |
| K831999 | FEMORAL CANAL SUCTION TAMPON | Richards Manufacturer Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832027 | ARGYLE YANKAVER SUCTION TUBE W/CONTROL | Sherwood Medical Co. | 1983-08-08 | Traditional | PDF ↗ |
| K830942 | SUCTION CATHETERS | Medovations, Inc. | 1983-04-14 | Traditional | PDF ↗ |
| K821342 | METAL BACKED ACETABULAR COMPONENT | Intermedics Orthopedics | 1982-05-21 | Traditional | PDF ↗ |
| K820718 | ARGYLE THORACIC CATHETERS | Sherwood Medical Co. | 1982-04-14 | Traditional | PDF ↗ |
| K820460 | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION | Superior Plastic Products Corp. | 1982-03-08 | Traditional | PDF ↗ |
| K812312 | STERILE WATER 4OZ. | Superior Plastic Products Corp. | 1981-11-13 | Traditional | PDF ↗ |
| K803206 | SUCTION PROBE | Bemis Health Care | 1981-01-21 | Traditional | PDF ↗ |
| K803187 | ARGYLE UNIVERSAL POOLE SUCTION TUBE | Sherwood Medical Co. | 1981-01-09 | Traditional | PDF ↗ |
| K801134 | MICROVAC | Progress Mankind Technology | 1980-05-30 | Traditional | PDF ↗ |
| K801127 | MACROVAC | Progress Mankind Technology | 1980-05-30 | Traditional | PDF ↗ |
| K800635 | C.C.-PAK | Respiratory Care, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K800234 | ABCO SUCTION CATHETER & KITS W/GLOVE&CUP | Abco Dealers, Inc. | 1980-02-26 | Traditional | PDF ↗ |
| K791801 | CONPHAR FINGERTIP SUCTION CONTROL | Conphar, Inc. | 1979-09-21 | Traditional | PDF ↗ |
| K782027 | HYSTERECTOMY T DRAIN | Davol, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K770983 | CATHETER THORACIC, AXIOM | Axiom Medical, Inc. | 1977-07-29 | Traditional | PDF ↗ |
| K770233 | STERILE SUCTION CATHETER W/CONTROL | Chesire Laboratories | 1977-04-05 | Traditional | PDF ↗ |
| K760586 | SUCTION KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-12 | Traditional | PDF ↗ |
Product code JOL · Class II · General Hospital. Data: openFDA.