Cleared Traditional

K102847 - DISPOSABLE ENDOMETRIAL SUCTION CURETTE (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.