Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)— 510(k) K252935

Substantially Equivalent

Foshan Pingchuang Medical Technology Co., Ltd.

FDA 510(k) clearance K252935 for Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml), Substantially Equivalent on 2025-12-15. Applicant: Foshan Pingchuang Medical Technology Co., Ltd..

Clearance details

Applicant: Foshan Pingchuang Medical Technology Co., Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-15
Decision date: 2025-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.