510(k) K254160
- Device
- VacHeal Negative Pressure Wound Therapy System
- Applicant
- VacHeal, LLC
- 510(k) number
- K254160
- Product code
- OKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-18
- Date received
- 2025-12-22
- Regulation
- 878.4683
- Classification name
- Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tiffany Morrison
- Address
- 40 E. Montgomery Ave. 4th Floor Ardmore PA US 19003 19003
FDA Registration Numbers#
- 3007663067
- 3009897021
- 1319660
- 1424263
- 3010256218
- 2953359
- 3005178245
- 3015967359
- 3010173425
- 3004713654
- 3006808392
Source Documents#
Other 510(k) Records For Product Code OKO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251156 | NPseal | Guard Medical, Inc. | 2025-05-15 |
| K250708 | NPseal | Guard Medical, Inc. | 2025-04-08 |
| K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024-08-15 |
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024-02-29 |
| K212971 | NPseal | Guard Medical, Inc. | 2022-02-10 |
| K211130 | NPseal | Guard Medical, Inc. | 2021-05-14 |
| K200305 | NPseal | Guard Medical, Inc. | 2020-05-26 |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | 2020-05-04 |
| K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015-11-19 |
| K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014-11-25 |
| K132080 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | 2014-03-12 |
| K133137 | CISNAP CLOSED INCISION SYSTEM | Spiracur, Inc. | 2014-02-25 |
| K113032 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | 2011-12-01 |
| K112341 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | 2011-08-29 |
| K111393 | SNAP (R) WOUND CARE SYSTEM | Spiracur, Inc. | 2011-07-28 |