510(k) K133336
- Device
- PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
- Applicant
- PJUR GROUP,LUXEMBOURG S.A.
- 510(k) number
- K133336
- Product code
- NUC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-24
- Date received
- 2013-10-29
- Regulation
- 884.5300
- Classification name
- Lubricant, Personal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CANDACE CEDERMAN
- Address
- 722 Arjean Dr. Wilmington NC US 28411 28411
FDA Registration Numbers#
- 2531449
- 3021033518
- 3029582965
- 3013770781
- 9610200
- 3014829931
- 3007829481
- 3006892202
- 1831301
- 3013215912
- 3003071219
- 3004569514
- 3011360380
- 8040641
- 3009939047
- 3010165308
- 3043139371
- 3015271338
- 3040313889
- 3013395518
- 3020512730
- 1649690
- 3015538858
- 3029906446
- 3012404174
- 3022754162
- 3010770024
- 1417367
- 3009482034
- 3007957048
- 3012262584
- 3036802562
- 3004737812
- 3010386378
- 2020372
- 3003963141
- 3039878168
- 3014759506
- 3040301765
- 9680135
- 3017732703
- 3008808138
- 3016842367
- 3038220293
- 3010419931
- 3009599096
- 3016616658
- 8020300
- 1811396
- 3012194887
- 3008080893
- 3003887639
- 2412672
- 3008469990
- 3003823186
- 2025292
- 3038613112
- 3027686087
- 3016931143
- 3030155386
- 3012909279
- 3013474580
- 3003676119
- 1450238
- 3004079477
- 3027974197
- 3010409218
- 3010164364
- 3011318803
- 3019880009
- 3015391081
- 1000375074
- 3004089975
- 2025771
- 3011630465
- 2938651
- 3003169402
- 3005113602
- 3003446042
Source Documents#
Other 510(k) Records For Product Code NUC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026-04-16 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | 2026-04-01 |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 2025-12-19 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 2025-12-12 |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025-09-09 |
| K250142 | Water-based Lubricant | Global Protection Corp. | 2025-08-08 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 2025-08-08 |
| K242712 | LubriZenzs | Sk Zen, LLC | 2025-06-04 |
| K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025-05-09 |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. | 2025-05-02 |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | 2025-03-20 |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare , Ltd. | 2025-01-21 |
Legacy Summary#
summary
FDA Review#
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