Cleared Traditional

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

K000026 · Apple Medical Corp. · Obstetrics & Gynecology
Mar 2000
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K000026 is an FDA 510(k) clearance for the APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER, a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Apple Medical Corp. (Marlboro, US). The FDA issued a Cleared decision on March 31, 2000, 86 days after receiving the submission on January 5, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.

Submission Details

510(k) Number K000026 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2000
Decision Date March 31, 2000
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HHK — Curette, Suction, Endometrial (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1175

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