Floret Ophthalmic Eye Spear

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

510(k) Number

K830262 ↗

FDA Product Code

HOZ

Device Class

Class II

Regulation

21 CFR Part 886.4790

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Floret Nasal Tampon

  Class I

  FDA 510(k) K830263 Active Cleared 24 Mar 1983

• Isovis Wound Protector

  Class II

  FDA 510(k) K832874 Active Cleared 26 Sep 1983

• Floret Gauze Packing

  Unclassified

  FDA 510(k) K830278 Active Cleared 29 Mar 1983

• Countway Sys. Soiled Sponges-Blood Los

  Class I

  FDA 510(k) K830273 Active Cleared 28 Feb 1983

• Floret Drain/Tracheotomy Sponge

  Unclassified

  FDA 510(k) K830265 Active Cleared 29 Mar 1983

• Floret Foam Prep Sponge

  Class I

  FDA 510(k) K833626 Active Cleared 17 Feb 1984

See all devices from Ritmed, Inc. →

• What is the primary purpose of the Floret Ophthalmic Eye Spear in surgical settings?

  The Floret Ophthalmic Eye Spear is designed as an absorbent device specifically for ophthalmic procedures. Its primary purpose is to control and remove fluids from the eye during surgical or diagnostic interventions, ensuring a clear and dry operative field.

• Is the Floret Ophthalmic Eye Spear intended for reuse, or is it meant to be used only once?

  The Floret Ophthalmic Eye Spear is explicitly supplied as a single-use device. This ensures sterility and safety for each procedure, as reuse could compromise its sterile integrity and effectiveness.

• How should the Floret Ophthalmic Eye Spear be stored to maintain its usability?

  Since the device is sterile and single-use, it must be stored in a clean, dry environment protected from contamination. The packaging should remain intact until immediately before use to preserve sterility and prevent exposure to dust or moisture.

• Are there different sizes or models available for the Floret Ophthalmic Eye Spear?

  Based on the provided data, the Floret Ophthalmic Eye Spear is supplied in a standardized form without specified size variations. It is designed as a single, consistent tool for general ophthalmic fluid absorption.

• What regulatory pathway was followed for the approval of the Floret Ophthalmic Eye Spear?

  The Floret Ophthalmic Eye Spear received FDA clearance through a 510(k) submission (K830262) under the Traditional clearance type. It was reviewed by the Ophthalmic (OP) Advisory Committee and classified as a Class II device under FDA regulation 886.4790, with a decision of Substantially Equivalent (SESE).