Cleared Traditional

K991895 - RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)

K991895 is an FDA 510(k) clearance for RAMPIPELLA, manufactured by Ri Mos. S.R.L.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K991895 · Ri Mos. S.R.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
70d
Days
Class 2
Risk

K991895 is an FDA 510(k) clearance for the RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217). Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K991895

510(k) Number K991895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 161d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHK Device Classification - Class 2, Special Controls

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHK Curette, Suction, Endometrial (and Accessories)

All 34
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K991895.
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc. · May 2000
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K000026 · Apple Medical Corp. · Mar 2000
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926 · Ri Mos. S.R.L. · Oct 1999
ENDOMETRIAL SAMPLER
K990387 · U.A. Medical Products, Inc. · Apr 1999
SELECTCELLS(TM) MINI
K974819 · Select Medical Systems, Inc. · Mar 1998
CPR D & C TRAY
K960239 · Custom Pack Reliability · May 1996
K991895 · RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
Download PDF FDA Summary Ri Mos. S.R.L.