Data / Medical devices / United States / Pensar Medical
Pensar Medical: FDA-registered device maker in Houston, TX, United States, 3 510(k) clearances
Pensar Medical is registered with the FDA (registration 3007793449) in Houston, TX, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 23, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007793449
- Address
- 109 N Post Oak Ln., Suite 525, Houston, TX, United States, 77024
- Owner or operator
- Pensar Medical (10043309)
- Roles
- Specification developer
- First device listed
- February 4, 2013
- Registered through
- 2026
- Brand names listed
- MicroDoc Micro Wound Therapy System, WoundPro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2020 | K200223 | PocketDoc Micro Wound Therapy System | OMP | Substantially Equivalent | Pensar Medical, LLC | accessdata.fda.gov |
| December 1, 2016 | K150960 | WoundPro Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Pensar Medical, LLC | accessdata.fda.gov |
| January 24, 2011 | K100823 | WOUND PRO APEX | OMP | Substantially Equivalent | Accuro Medical Products, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2012 | 63064 | Class II | Terminated | Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, | Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.