# K974022: VAPR

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Jan 12, 1998 after 90 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.
28 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories: named in the summary without a submission number

## Most influential descendants
- K041810: Serfas Energy System (2004), 17 descendants of its own
- K992876: Vapr 2.3 MM Side Effect Electrode for Use with Vapr System (1999), 12 descendants of its own
- K992406: Vapr 2.3MM End Effect Electrode for Use with Vapr System (1999), 12 descendants of its own
- K041135: Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes (2004), 10 descendants of its own
- K082643: 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode with Integrate (2008), 9 descendants of its own

## Indications for use
The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues.

Source page: https://510kreport.com/device/K974022
Methodology: https://510kreport.com/methodology