Enviro Sharp Solutions 3
by Industrial Water Solutions, Inc.
510(k) K083511
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083511 | Date3 Mar 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MMK
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Enviro Sharp Solutions 3 is a container for sharps, classified as a medical device under device class 2. It is designed for the containment of needles, sharps waste, and other infectious waste generated in healthcare settings.
It is intended for use by healthcare providers in hospitals, laboratories, medical clinics, veterinary clinics, and similar facilities. The device is supplied as a reusable container and has received FDA 510(k) clearance under K083511, with a determination of substantial equivalence.
Other devices from Industrial Water Solutions, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of facilities can use the Enviro Sharp Solutions 3 for sharps disposal, and why is it suitable for them?
The Enviro Sharp Solutions 3 is designed for healthcare providers in hospitals, laboratories, medical clinics, veterinary clinics, and similar settings. It is suitable for these environments because it is specifically engineered to safely contain needles, sharps waste, and other infectious waste generated during medical procedures, reducing the risk of accidental needle sticks and ensuring compliance with sharps disposal regulations.
Is the Enviro Sharp Solutions 3 intended for single-use or reusable applications, and how does this affect its maintenance?
The Enviro Sharp Solutions 3 is supplied as a reusable container, meaning it is built to withstand repeated use in healthcare settings. Since it is reusable, proper cleaning and maintenance protocols must be followed to ensure its integrity and safety for ongoing use, including regular disinfection and inspection for damage or wear.
What regulatory pathway was followed for FDA clearance of the Enviro Sharp Solutions 3, and what does this mean for buyers?
The Enviro Sharp Solutions 3 received FDA 510(k) clearance under the traditional review pathway, with a determination of substantial equivalence to a predicate device. This means the device was evaluated by the FDA to ensure it is as safe and effective as a previously cleared sharps container, providing buyers with confidence in its compliance with U.S. regulatory standards for medical devices.
Are there different sizes or models available for the Enviro Sharp Solutions 3, and how can buyers determine which one fits their needs?
The Enviro Sharp Solutions 3 is listed under multiple FEI numbers (e.g., 3015821396, 3004425647), which may correspond to variations in size or capacity. While exact dimensions or model-specific details aren’t provided, buyers should consult the manufacturer’s documentation or sales team to select the appropriate size based on their facility’s sharps waste volume and disposal requirements.
How is the Enviro Sharp Solutions 3 classified under FDA regulations, and what does this classification imply for its use?
The Enviro Sharp Solutions 3 is classified as a Class II medical device under FDA regulations. This classification implies that while it poses moderate risk, it has special controls in place to ensure its safety and effectiveness, such as performance standards and post-market surveillance. Buyers can rely on this classification to confirm that the device undergoes rigorous evaluation before use in healthcare settings.