Vapr

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K974022 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Mitek Absorbable Toggle Anchor

  Class II

  FDA 510(k) K964013 Active Cleared 24 Feb 1997

• Resolve Quickanchor

  Class II

  FDA 510(k) K993575 Active Cleared 29 Dec 1999

• Mitek Knotless Anchor

  Class II

  FDA 510(k) K974345 Active Cleared 13 Feb 1998

• Mitek Btb Absorbable (Pla) Cross Pin

  Class II

  FDA 510(k) K974341 Active Cleared 16 Apr 1998

• Rididfix 2.7mm Btb Cross Pin Kit

  Class II

  FDA 510(k) K013781 Active Cleared 6 Feb 2002

• BioKnotless Anchor

  Class II

  FDA 510(k) K002639 Active Cleared 11 May 2001

See all devices from Mitek Products →

• What is the VAPR Radiofrequency Electrode System used for?

  The VAPR Radiofrequency Electrode System is designed specifically for arthroscopic surgeries, where it delivers controlled radiofrequency energy to perform soft tissue ablation, contouring, cutting, and hemostasis. This makes it ideal for minimally invasive joint procedures where precision and reduced trauma are critical.

• How is the VAPR system supplied, and what models are available?

  The VAPR system is supplied as a reusable unit, paired with disposable electrode probes. Available models include the VAPR S90, VAPR LD, VAPR LP, VAPR Premiere50, VAPR 90 Degree, VAPR S50, and VAPR Premiere90, each tailored for specific surgical applications.

• Is the VAPR system single-use or reusable?

  The VAPR system itself is reusable, but it requires the use of disposable electrode probes for each procedure. This design ensures sterility and reduces cross-contamination risks in sterile operating room environments.

• Where and how should the VAPR system be stored?

  The VAPR system must be stored in accordance with the manufacturer’s guidelines to maintain functionality and safety. Since it is intended for sterile environments, storage should be in a clean, dry location away from direct sunlight or extreme temperatures. Disposable probes should be stored in their original packaging until use.

• What regulatory clearance does the VAPR system hold?

  The VAPR Radiofrequency Electrode System holds FDA 510(k) clearance under the classification of general plastic surgery devices, with a clearance number of K974022. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards.