Cleared Traditional

CARAPACE PELVIC EXAM TRAYS

K931822 · Carapace, Inc. · Obstetrics & Gynecology

Mar 1994

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K931822 is an FDA 510(k) clearance for the CARAPACE PELVIC EXAM TRAYS, a Pelvic Exam Kit (Class II — Special Controls, product code MLT), submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on March 7, 1994, 333 days after receiving the submission on April 8, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K931822 FDA.gov
FDA Decision	Cleared SESK
Date Received	April 08, 1993
Decision Date	March 07, 1994
Days to Decision	333 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

Device Classification

Product Code	MLT — Pelvic Exam Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4530
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market.