Cleared Special

K050308 - THERMAL CAUTERY PROBE
(FDA 510(k) Clearance)

K050308 · Starion Instruments · Ophthalmic

Feb 2005

Decision

17d

Days

Class 2

Risk

K050308 is an FDA 510(k) clearance for the THERMAL CAUTERY PROBE, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on February 25, 2005, 17 days after receiving the submission on February 8, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K050308 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2005
Decision Date	February 25, 2005
Days to Decision	17 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF