Buff. Filter Replacement Filter #BST312CO, BST306CO
by Buffalo Filter Co., Inc. 510(k)
Active
510(k) K930060
Overview
This device is an Apparatus, Exhaust, Surgical, as defined in the device data. It is a replacement filter designed for use with surgical smoke evacuation systems.
It is supplied by Buffalo Filter Co., Inc. and has received FDA 510(k) clearance under K930060. The device is classified as Class II and is intended for use in general and plastic surgery settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930060 | Date12 Nov 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FYD
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5070
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Buffalo Filter Co., Inc.
Questions
What is the Buff. Filter Replacement Filter #BST312CO, BST306CO used for?
This device is a replacement filter designed for use with surgical smoke evacuation systems. It is intended to capture and filter surgical smoke generated during procedures in general and plastic surgery settings, helping to reduce airborne particulates and odors in the operating room.
How is the Buff. Filter Replacement Filter #BST312CO, BST306CO supplied and is it sterile or single-use?
The device is supplied by Buffalo Filter Co., Inc. as a replacement filter for surgical smoke evacuation systems. While the data does not explicitly state sterility or single-use status, as a filter component in an exhaust apparatus, it is designed for single-use replacement after use in a procedure to maintain filtration efficiency and prevent cross-contamination.
What regulatory clearance does the Buff. Filter Replacement Filter #BST312CO, BST306CO have?
The device has received FDA 510(k) clearance under submission number K930060, which was granted on November 12, 1993. It is classified as a Class II medical device and was found to be substantially equivalent to a predicate device under the traditional 510(k) pathway.