510(k) K212971
- Device
- NPseal
- Applicant
- Guard Medical Inc
- 510(k) number
- K212971
- Product code
- OKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-10
- Date received
- 2021-09-17
- 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
- No
Applicant Contact#
- Contact
- Machiel Van Der Leest
- Address
- 1221 Brickwell Ave., Suite 900 Miami FL US 33131 33131
FDA Registration Numbers#
- 3009897021
- 1424263
- 3005178245
- 3004713654
- 1319660
- 3010256218
- 3010173425
- 2953359
- 3007663067
- 3006808392
- 3015967359
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 |
| 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 |
| K111006 | CI-SNAP WOUND CARE SYSTEM | Spiracur, Inc. | 2011-07-21 |
Legacy Summary#
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FDA Review#
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