Cleared Traditional

K910088 - SCITECH BI-MANUAL ADAPTER CLIPS
(FDA 510(k) Clearance)

K910088 · Scitech Industries Partnership · Ophthalmic device

Apr 1991

Decision

89d

Days

Class 2

Risk

K910088 is an FDA 510(k) clearance for the SCITECH BI-MANUAL ADAPTER CLIPS. This device is classified as a Apparatus, Cautery, Radiofrequency, Battery-powered (Class II - Special Controls, product code HQQ).

Submitted by Scitech Industries Partnership (Woodcliff Lake, US). The FDA issued a Cleared decision on April 8, 1991, 89 days after receiving the submission on January 9, 1991.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K910088 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 1991
Decision Date	April 08, 1991
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—