510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Pensar Medical

Houston, TX, US

Pensar Medical appears in FDA device records in Houston, TX. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Pensar Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Accuro Medical Product LLCenforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Pensar Medical between 2016 and 2020. The busiest year on record is 2016, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pensar Medical, by decision year
YearClearances
20161
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200223PocketDoc™ Micro Wound Therapy SystemOMPSubstantially Equivalent
K150960WoundPro Negative Pressure Wound Therapy SystemOMPSubstantially Equivalent

Registered establishments

FDA registered establishments for Pensar Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077934493007793449Pensar Medical109 N Post Oak Ln., Suite 525, Houston, TX 77024 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0009-2013Wound 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, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain