Cleared Traditional

K974313 - HYDROFERA SURGICAL SPEAR (FDA 510(k) Clearance)

K974313 · Hydrofera, LLC · Ophthalmic device
Mar 1998
Decision
105d
Days
Class 2
Risk

K974313 is an FDA 510(k) clearance for the HYDROFERA SURGICAL SPEAR. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on March 2, 1998, 105 days after receiving the submission on November 17, 1997.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K974313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date March 02, 1998
Days to Decision 105 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HOZ - Sponge, Ophthalmic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 886.4790