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K Number
K974313
Device Name
HYDROFERA SURGICAL SPEAR
Manufacturer
HYDROFERA, LLC.
Date Cleared
1998-03-02

(105 days)

Product Code
HOZ
Regulation Number
886.4790
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.

Device Description

Ophthalmic Sponge

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an ophthalmic sponge and outlines regulatory information, but it does not detail any acceptance criteria, study methodologies, performance metrics, or ground truth establishment for a device.

§ 886.4790 Ophthalmic sponge.

(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.