3M FLUID IRRIGATION SYSTEM— 510(k) K941388
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K941388 for 3M FLUID IRRIGATION SYSTEM, Substantially Equivalent on 1994-10-07. Applicant: 3M Healthcare. Device class: 2.
Clearance details
- Applicant
- 3M Healthcare
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code HRX
view allMore clearances from 3M Healthcare
view all- K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K191355 — 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
- K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
- K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.