Cleared Traditional

K090432 - HEMORPEX SYSTEM

K090432 is an FDA 510(k) clearance for HEMORPEX SYSTEM, manufactured by Angiologica B. M. Srl. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K090432 · Angiologica B. M. Srl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
99d
Days
Class 2
Risk

K090432 is an FDA 510(k) clearance for the HEMORPEX SYSTEM. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Angiologica B. M. Srl (San Martino Siccomario, Pavia, IT). The FDA issued a Cleared decision on May 29, 2009 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Angiologica B. M. Srl devices

FDA 510(k) Submission Details - K090432

510(k) Number K090432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date May 29, 2009
Days to Decision 99 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 131d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FER Device Classification - Class 2, Special Controls

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FER Anoscope And Accessories

All 21
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K090432.
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647 · Thd Spa · Mar 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
K091490 · Thd Spa · Jun 2009
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
K080132 · Thd Spa · Apr 2008
SELF-LIGHT DISPOSABLE ANOSCOPE
K070913 · Sapimed S.P.A. · Aug 2007
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623 · Cook Ireland, Ltd. · Sep 2006