Versaphage

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

510(k) Number

K851272 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Versablade

  Class I

  FDA 510(k) K852633 Active Cleared 4 Nov 1985

• Versatome I

  Class II

  FDA 510(k) K820008 Active Cleared 22 Feb 1982

• Glomark

  Class I

  FDA 510(k) K830703 Active Cleared 28 Apr 1983

• Alphamedix I/a Hand-Piece, 500-001

  Class II

  FDA 510(k) K830812 Active Cleared 8 Jun 1983

• Disposable Surgical Garments

  Class II

  FDA 510(k) K820363 Active Cleared 8 Mar 1982

• Versablade

  Class I

  FDA 510(k) K852706 Active Cleared 4 Nov 1985

• What is the Versaphage used for in ophthalmic procedures?

  The Versaphage is an ophthalmic instrument designed for vitreous aspiration and cutting during eye surgery procedures. It assists in the removal and cutting of vitreous humor during ophthalmic operations.

• Is the Versaphage a single-use or reusable instrument?

  The Versaphage is supplied as a reusable instrument and is not specified for single-use. It is designed to be used multiple times in appropriate clinical settings following proper sterilization protocols.

• What is the regulatory classification of the Versaphage?

  The Versaphage is authorized under FDA 510(k) clearance with product code HQE and is classified as a Class II medical device for ophthalmic use. It has been determined to be substantially equivalent to predicate devices.

• Is the Versaphage MRI compatible?

  The Versaphage is not indicated as MRI compatible. It is an AC-powered device designed for traditional ophthalmic surgical settings where MRI compatibility is not a specified feature.