PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION— 510(k) K000265
Substantially EquivalentPrimary Care Solutions, Inc.
FDA 510(k) clearance K000265 for PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION, Substantially Equivalent on 2001-07-12. Applicant: Primary Care Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Primary Care Solutions, Inc.
- Product code
- Code JOL
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringwood, NJ, US
Recent devices under product code JOL
view all- K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
- K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
- K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
- K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
- K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
More clearances from Primary Care Solutions, Inc.
view allAdverse events under product code JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.