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

Hillsborough, CA, US

Ninepoint Medical, Inc. appears in FDA device records in Hillsborough, CA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Ninepoint Medical, Inc. between 2011 and 2019. The busiest year on record is 2018, with 2. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ninepoint Medical, Inc., by decision year
YearClearances
20111
20121
20131
20151
20161
20182
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K191117NvisionVLE Low-profile Optical ProbeNQQUnknown
K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNQQUnknown
K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNQQUnknown
K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNQQUnknown
K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNQQUnknown
K120800NVISION VLE IMAGING SYSTEMNQQUnknown
K121195NVISION VLE IMAGING SYSTEM NVISION VLE CATHETERNQQSubstantially Equivalent
K112770NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETERNQQSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1781-2018NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.Distal tips of the probes may detach from the probe shaft during use.Class IITerminated

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