510(k) K232093
- Device
- Woo More Play Coconut Love Oil
- Applicant
- Woo Essentials, Inc.
- 510(k) number
- K232093
- Product code
- NUC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-01
- Date received
- 2023-07-13
- 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
- Mackie Swan
- Address
- 1801 Brackenridge St. A Austin TX US 78704 78704
FDA Registration Numbers#
- 3016931143
- 3010408703
- 3010092818
- 3006892202
- 3013395518
- 3003631744
- 3016842367
- 2650087
- 3008875046
- 3045010277
- 9610200
- 3010770024
- 3003896222
- 3008808138
- 3012482333
- 8020300
- 3004737812
- 3039878168
- 3029906446
- 3011318803
- 3027686087
- 3014759506
- 3015686320
- 3019880009
- 8040641
- 3015271338
- 3003887639
- 3045006668
- 3014317667
- 3013961642
- 2938651
- 3010419931
- 2531449
- 2020372
- 3043139371
- 3012060843
- 3004569514
- 3042254987
- 3008469990
- 3012909279
- 3012477715
- 3027974197
- 3009599096
- 3022754162
- 1063707
- 3030155386
- 1221895
- 3010409218
- 3013215912
- 2124143
- 3029905133
- 3002840999
- 2025771
- 3029582965
- 1811396
- 3009939047
- 3013414814
- 3015272252
- 1000375074
- 3019735068
- 3016616658
- 3013441423
- 3010164364
- 3015538858
- 1450238
- 2434221
- 3007957048
- 3008080893
- 3011360380
- 3011015568
- 3009282298
- 3017022534
- 3015391081
- 2022474
- 3003446042
- 3003071219
- 3007067755
- 3000220439
- 1831301
- 3038220293
Source Documents#
Other 510(k) Records For Product Code NUC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | 2026-07-09 |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026-07-06 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026-06-22 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026-06-11 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | 2026-06-09 |
| 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 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 2025-08-08 |
| K250142 | Water-based Lubricant | Global Protection Corp. | 2025-08-08 |