MIST Reducer Sleeves
by Minimally Invasive Surgical Technologies, Inc. 510(k)
Active
510(k) K951398
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951398 | Date3 May 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
MIST Reducer Sleeves are a device used in minimally invasive surgical procedures. They are designed to reduce mist or aerosol generation during endoscopic or laparoscopic interventions.
The device is supplied non-sterile and is intended for single-use. It is used in clinical settings such as gastroenterology and urology procedures. The device received FDA 510(k) clearance under K951398 and is classified under product code GCJ.
Other devices from Minimally Invasive Surgical Technologies, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the MIST Reducer Sleeve used for?
The MIST Reducer Sleeve is designed to reduce mist or aerosol generation during endoscopic or laparoscopic interventions, helping to improve visibility and safety in minimally invasive surgical procedures.
How is the MIST Reducer Sleeve supplied and is it reusable?
The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after a procedure to maintain safety and performance.
In which clinical specialties is the MIST Reducer Sleeve commonly used?
The MIST Reducer Sleeve is used in clinical settings such as gastroenterology and urology procedures, where endoscopic or laparoscopic techniques are employed and aerosol reduction is beneficial.