Cleared Traditional

RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)

K991895 · Ri Mos. S.R.L. · Obstetrics & Gynecology
Aug 1999
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K991895 is an FDA 510(k) clearance for the RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217), a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on August 12, 1999, 70 days after receiving the submission on June 3, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.

Submission Details

510(k) Number K991895 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1999
Decision Date August 12, 1999
Days to Decision 70 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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