Sterile Water Solution Catalog # 10000
FDA 510(k) K904216 · Superior Healthcare Group, Inc.
510(k) numberK904216
Submission
- Device name
- Sterile Water Solution Catalog # 10000
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- September 12, 1990
- Decision date
- November 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOL – Catheter And Tip, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code JOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051370 | Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional | Baxter Healthcare Corp | 08/12/2005SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | Welcon, Inc. | 05/01/2001SE |
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | Automatic Liquid Packaging, Inc. | 10/25/2000SE |
| K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974758 | Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974397 | Sterile Saline for Catheter CareJOL · Traditional | Baxter Healthcare Corp | 02/10/1998SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | Welcon, Inc. | 02/05/1998SE |
| K972372 | Germ Trapper Suction Tube HolderJOL · Traditional | Rzv Medical Specialties, Inc. | 12/11/1997SE |
More from Rzv Medical Specialties, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925530 | Instrument WarmerFMS · Traditional | 06/18/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | 03/15/1993SE |
| K905755 | Non-Sterile Patient Examination GlovesLYY · Traditional | 03/08/1991SE |
| K903347 | Sodium Chloride SolutionFOZ · Traditional | 12/13/1990SE |
| K903340 | Sterile Urethral Catheter Procedure KitsFCM · Traditional | 10/04/1990SESD |
| K896321 | No. 34100 - 8 FR & No. 34400 - 14 FR Closed Trach.BSY · Traditional | 11/13/1989SE |
| K894676 | Sterile Latex Exam GlovesLYY · Traditional | 08/17/1989SE |
| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | 06/22/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was Sterile Water Solution Catalog # 10000 cleared by the FDA?
Sterile Water Solution Catalog # 10000 (K904216) received a 510(k) decision of Substantially Equivalent on November 16, 1990, 65 days after the submission was received.
What is the product code of K904216?
The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.