Cleared Traditional

K040189 - ENDOMETRIAL SAMPLING SYRINGE

K040189 is an FDA 510(k) clearance for ENDOMETRIAL SAMPLING SYRINGE, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K040189 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
250d
Days
Class 2
Risk

K040189 is an FDA 510(k) clearance for the ENDOMETRIAL SAMPLING SYRINGE. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Rocket Medical Plc (Stamford, US). The FDA issued a Cleared decision on October 4, 2004 after a review of 250 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Rocket Medical Plc devices

FDA 510(k) Submission Details - K040189

510(k) Number K040189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2004
Decision Date October 04, 2004
Days to Decision 250 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
89d slower than avg
Panel avg: 161d · This submission: 250d
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 27
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K040189.
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K102847 · Jiangsu Suyun Medical Materials Co., Ltd. · Apr 2011
THE PANPAC SUCTION CURETTE
K092982 · Panpac Medical Corporation · Jul 2010
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K051294 · Femspec LLC · Dec 2005
MAS WITH OR WITHOUT SYRINGE
K021876 · Marina Medical Instruments, Inc. · Apr 2003
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628 · Bioteque America, Inc. · May 2002
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K001555 · Sims Portex , Ltd. · Aug 2000