# K170582: Saf-T-Vac Smoke and Fluid Evacuator

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Technology Laboratories, Inc.
- Decided: Apr 14, 2017 after 45 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities. The Saf-T-Vac® is intended to be used with currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

Source page: https://510kreport.com/device/K170582
Methodology: https://510kreport.com/methodology