Cleared Traditional

BLADEWORKS DISPOSABLE ALK TUBING

K993591 · Blade Works, Inc. · Ophthalmic
Dec 1999
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K993591 is an FDA 510(k) clearance for the BLADEWORKS DISPOSABLE ALK TUBING, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Blade Works, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on December 28, 1999, 67 days after receiving the submission on October 22, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K993591 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1999
Decision Date December 28, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code KYG — Device, Irrigation, Ocular Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4360

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