MAUSER PG II Sharps Container
510(k) K170513
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170513 | Date1 Nov 2017 | 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- Withdrawn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, 6 Oct 2026
The MAUSER PG II Sharps Container is a Class II medical device designed for the containment of sharps waste. It is intended for use on sites with no unsupervised patient access and is available for over-the-counter use.
This single-use, non-sterile device may require the manufacturer's pedal bin frame when used on medication carts. The pedal bin frame is constructed of stainless steel and comes fully preassembled. The device has FDA 510(k) clearance with product code MMK and is regulated under number 880.5570.
Questions
AI-generated answers, 6 Oct 2026
What is the MAUSER PG II Sharps Container used for?
The MAUSER PG II Sharps Container is designed for the containment of sharps waste. It is intended for use on sites with no unsupervised patient access and is available for over-the-counter use.
Is the MAUSER PG II Sharps Container single-use or reusable?
The MAUSER PG II Sharps Container is a single-use device. It is non-sterile and may require the manufacturer's pedal bin frame when used on medication carts.
What are the regulatory details for the MAUSER PG II Sharps Container?
The MAUSER PG II Sharps Container has FDA 510(k) clearance with product code MMK and is regulated under number 880.5570. It is classified as a Class II medical device.
Does the MAUSER PG II Sharps Container come with a pedal bin frame?
The pedal bin frame is constructed of stainless steel and comes fully preassembled. It may be required when the sharps container is used on medication carts.