Saf-T-Vac Smoke and Fluid Evacuator
FDA 510(k) K170582 · Surgical Technology Laboratories, Inc.
510(k) numberK170582
Submission
- Device name
- Saf-T-Vac Smoke and Fluid Evacuator
- Applicant
- Surgical Technology Laboratories, Inc.
Lugoff, SC, US - Received
- February 28, 2017
- Decision date
- April 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K021889 | Surgiform Augmentation Material (S.F.A.M.)KKY · Traditional | 10/16/2002SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | 11/20/1998SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | 11/20/1998SE |
| K983754 | Standard ChinFWP · Special | 11/20/1998SE |
| K964443 | Surgiform Anatomical MalarLZK · Traditional | 12/20/1996SE |
| K840835 | Straith Drain InserterFZX · Traditional | 04/23/1984SE |
| K831078 | Straith Oral AirwayCAE · Traditional | 06/24/1983SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | 06/17/1980SE |
| K801072 | Straith Nasal SplintFYI · Traditional | 06/17/1980SE |
| K801075 | Straith Chisel ForcepsGEN · Traditional | 05/20/1980SE |
Questions and answers
When was Saf-T-Vac Smoke and Fluid Evacuator cleared by the FDA?
Saf-T-Vac Smoke and Fluid Evacuator (K170582) received a 510(k) decision of Substantially Equivalent on April 14, 2017, 45 days after the submission was received.
What is the product code of K170582?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.