Cleared Traditional

K171730 - FuckWater

K171730 is an FDA 510(k) clearance for FuckWater, manufactured by Non-Friction Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K171730 · Non-Friction Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
87d
Days
Class 2
Risk

K171730 is an FDA 510(k) clearance for the FuckWater. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Non-Friction Products, Inc. (Toronto, CA). The FDA issued a Cleared decision on September 7, 2017 after a review of 87 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.

View all Non-Friction Products, Inc. devices

FDA 510(k) Submission Details - K171730

510(k) Number K171730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2017
Decision Date September 07, 2017
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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

Monroe Medical Device Consulting, LLC
James W. Monroe

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 - NUC Lubricant, Personal

All 212
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