Cleared Traditional

K060797 - NAKED

K060797 is an FDA 510(k) clearance for NAKED, manufactured by Veraxis Int'L, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K060797 · Veraxis Int'L, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
14d
Days
Class 2
Risk

K060797 is an FDA 510(k) clearance for the NAKED. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Veraxis Int'L, Inc. (New York, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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.

FDA 510(k) Submission Details - K060797

510(k) Number K060797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date April 07, 2006
Days to Decision 14 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 161d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K060797.
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
K062730 · Biogreen Medical Sdn. Bhd. · Oct 2006
ZEUS MALE CONDOM APPLICATOR
K052206 · Condax, LLC · Sep 2006
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · Cupid Condom, Ltd. · Apr 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006
MALE NATURAL RUBBER LATEX CONDOM
K053367 · Innolatex Sdn. Bhd · Feb 2006
VIELLE LUBRICANT
K051288 · Cst Medical Limited · Feb 2006

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060797 · NAKED
Download PDF FDA Summary Veraxis Int'L, Inc.