Cleared Traditional

K911432 - ACCELLON CERVICAL BIOSAMPLER

K911432 is an FDA 510(k) clearance for ACCELLON CERVICAL BIOSAMPLER, manufactured by Medscand AB. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 885-day FDA review.

K911432 · Medscand AB · Obstetrics & Gynecology device
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Sep 1993
Decision
885d
Days
Class 2
Risk

K911432 is an FDA 510(k) clearance for the ACCELLON CERVICAL BIOSAMPLER. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Medscand AB (Malmo, SE). The FDA issued a Cleared decision on September 3, 1993 after a review of 885 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K911432

510(k) Number K911432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1991
Decision Date September 03, 1993
Days to Decision 885 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
724d slower than avg
Panel avg: 161d · This submission: 885d
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 61
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K911432.
CYTOLOGY BRUSH
K933628 · Bioteque America, Inc. · Mar 1994
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
EXACT-TOUCH
K915844 · Baal Assoc., Inc. · Jan 1994
CYTO PAK PAP SMEAR KIT
K923143 · International Medical Equipment Brokers, Inc. · Jul 1993
CELL COLLECTING BRUSH
K924908 · Anderson Winn Paper Co. · Apr 1993
CELL SWEEP
K911327 · Reza S Mohajer, M.D. C/O Krass & Young · May 1991
K911432 · ACCELLON CERVICAL BIOSAMPLER
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