Cleared Traditional

K102847 - DISPOSABLE ENDOMETRIAL SUCTION CURETTE

K102847 is an FDA 510(k) clearance for DISPOSABLE ENDOMETRIAL SUCTION CURETTE, manufactured by Jiangsu Suyun Medical Materials Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K102847 · Jiangsu Suyun Medical Materials Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
197d
Days
Class 2
Risk

K102847 is an FDA 510(k) clearance for the DISPOSABLE ENDOMETRIAL SUCTION CURETTE. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Jiangsu Suyun Medical Materials Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 14, 2011 after a review of 197 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 Jiangsu Suyun Medical Materials Co., Ltd. devices

FDA 510(k) Submission Details - K102847

510(k) Number K102847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date April 14, 2011
Days to Decision 197 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
37d slower than avg
Panel avg: 160d · This submission: 197d
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 15
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K102847.
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K240434 · Li Medical Corporation , Ltd. · Sep 2024
CrossGlide ETS Plus
K201952 · Crossbay Medical · Aug 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · Crossbay Medical · Mar 2020
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc. · May 2000
CPR D & C TRAY
K960239 · Custom Pack Reliability · May 1996
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp. · Feb 1988