Cleared Traditional

K950780 - AMSINO CERVICAL SCRAPER

K950780 is an FDA 510(k) clearance for AMSINO CERVICAL SCRAPER, manufactured by Amsino Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K950780 · Amsino Intl., Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
154d
Days
Class 2
Risk

K950780 is an FDA 510(k) clearance for the AMSINO CERVICAL SCRAPER. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Amsino Intl., Inc. (City Of Industry, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 154 days - an extended review 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: 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.

FDA 510(k) Submission Details - K950780

510(k) Number K950780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date July 25, 1995
Days to Decision 154 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
7d faster than avg
Panel avg: 161d · This submission: 154d
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 55
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K950780.
PURITAN FOAM TIP SWAB MODEL 2197
K961934 · Hardwood Products Co., LP · Jul 1996
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
K954562 · Gynetech, Inc. · Dec 1995
CERVEX-BRUSH PAP KIT
K941472 · Rovers Diagnostic Devices · Feb 1995
VIBA-BRUSH
K933870 · Rovers B.V. · Jan 1995
PELVIC EXAM TRAY
K934732 · Medcare Custom Packaging, Inc. · Dec 1994
K950780 · AMSINO CERVICAL SCRAPER
Download PDF Amsino Intl., Inc.