Cleared Traditional

ENDOCERVICAL BLOCK NEEDLE

K021224 · Wallach Surgical Devices, Inc. · Obstetrics & Gynecology
Jul 2002
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K021224 is an FDA 510(k) clearance for the ENDOCERVICAL BLOCK NEEDLE, a Set, Anesthesia, Paracervical (Class II — Special Controls, product code HEE), submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on July 12, 2002, 86 days after receiving the submission on April 17, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5100.

Submission Details

510(k) Number K021224 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2002
Decision Date July 12, 2002
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HEE — Set, Anesthesia, Paracervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5100

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