Cleared Traditional

K991593 - ORIBRUSH - STANDARD - B002

K991593 is an FDA 510(k) clearance for ORIBRUSH - STANDARD - B002, manufactured by Orifice Medical AB. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K991593 · Orifice Medical AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
53d
Days
Class 2
Risk

K991593 is an FDA 510(k) clearance for the ORIBRUSH - STANDARD - B002. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Orifice Medical AB (Ystad, SE). The FDA issued a Cleared decision on June 29, 1999 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 Orifice Medical AB devices

FDA 510(k) Submission Details - K991593

510(k) Number K991593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1999
Decision Date June 29, 1999
Days to Decision 53 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 160d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HHT Spatula, Cervical, Cytological

All 22
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K991593.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · Orifice Medical AB · Jun 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · Harwill Medical (Pty) , Ltd. · Mar 1999
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · Andwin Scientific · Dec 1998
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · Andwin Scientific · Nov 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · Canadian Medical Brush, Inc. · Apr 1998