Cleared Traditional

K001555 - SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

K001555 is an FDA 510(k) clearance for SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, manufactured by Sims Portex , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K001555 · Sims Portex , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
76d
Days
Class 2
Risk

K001555 is an FDA 510(k) clearance for the SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Sims Portex , Ltd. (Hythe, Kent, GB). The FDA issued a Cleared decision on August 2, 2000 after a review of 76 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.

View all Sims Portex , Ltd. devices

FDA 510(k) Submission Details - K001555

510(k) Number K001555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date August 02, 2000
Days to Decision 76 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
84d faster than avg
Panel avg: 160d · This submission: 76d
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 K001555.
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