Cleared Traditional

K021876 - MAS WITH OR WITHOUT SYRINGE

K021876 is an FDA 510(k) clearance for MAS WITH OR WITHOUT SYRINGE, manufactured by Marina Medical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K021876 · Marina Medical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
305d
Days
Class 2
Risk

K021876 is an FDA 510(k) clearance for the MAS WITH OR WITHOUT SYRINGE. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Marina Medical Instruments, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 8, 2003 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marina Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K021876

510(k) Number K021876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2002
Decision Date April 08, 2003
Days to Decision 305 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 160d · This submission: 305d
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 20
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K021876.
CrossGlide ETS Plus
K201952 · Crossbay Medical · Aug 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · Crossbay Medical · Mar 2020
ENDOMETRIAL SAMPLING SYRINGE
K040189 · Rocket Medical Plc · Oct 2004
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc. · May 2000
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926 · Ri Mos. S.R.L. · Oct 1999
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K991895 · Ri Mos. S.R.L. · Aug 1999