Cleared Traditional

CRYOTIP

K041562 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Aug 2004
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K041562 is an FDA 510(k) clearance for the CRYOTIP, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 9, 2004, 60 days after receiving the submission on June 10, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.

Submission Details

510(k) Number K041562 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2004
Decision Date August 09, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQH — Microtools, Assisted Reproduction (pipettes)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6130

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