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510(k) K261177

PINKSLIP Water-Based Personal Lubricant and Moisturizer by PINKSLIP, LLC — Product Code NUC

K261177 is an FDA 510(k) premarket notification submitted by PINKSLIP, LLC for the device "PINKSLIP Water-Based Personal Lubricant and Moisturizer". The FDA issued a decision of Substantially Equivalent on July 9, 2026. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2026
Date Received
April 10, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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.

Other clearances for product code NUC

  • K261909 — Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (July 6, 2026)
  • K254011 — Flow Water-Based Personal Lubricant (June 22, 2026)
  • K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (June 11, 2026)
  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)
  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)
  • K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30 (December 15, 2025)

FDA data resources