Cleared Traditional

PRESCOTT'S SURGICAL SPEAR

K003842 · Prescott'S, Inc. · Ophthalmic

Apr 2001

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K003842 is an FDA 510(k) clearance for the PRESCOTT'S SURGICAL SPEAR, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Prescott'S, Inc. (Monument, US). The FDA issued a Cleared decision on April 13, 2001, 122 days after receiving the submission on December 12, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number	K003842 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2000
Decision Date	April 13, 2001
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement