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

San Jose, CA, US

Prosurg, Inc appears in FDA device records in San Jose, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Prosurg, Inc between 2000 and 2016. The busiest year on record is 2007, with 4. The most recent is 2016, with 3.

Clearances by year, as a table
510(k) clearance decisions for Prosurg, Inc, by decision year
YearClearances
20002
20021
20032
20052
20061
20074
20121
20163
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaHRXSubstantially Equivalent
K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)EOQSubstantially Equivalent
K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)GCJSubstantially Equivalent
K120766ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)FAJSubstantially Equivalent
K072528ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIESJEYSubstantially Equivalent
K071138CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEMGXRSubstantially Equivalent
K070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIESJEYSubstantially Equivalent
K070846MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEMFTLSubstantially Equivalent
K060326LASERTX - DIODE LASER & DELIVERY SYSTEMGEXSubstantially Equivalent
K050488TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICESFASSubstantially Equivalent
K042780NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEMFAJSubstantially Equivalent
K030631ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESHFTLSubstantially Equivalent
K023257ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTXGEXSubstantially Equivalent
K023051INTRAUTERINE DELIVERY SYSTEM - INJECTORLKFSubstantially Equivalent
K001576EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPYNBVSubstantially Equivalent
K000124SENSATION -VACUUM ASSIST DEVICESLKYSubstantially Equivalent

Registered establishments

FDA registered establishments for Prosurg, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30067891543006789154Prosurg, Inc2193 Trade Zone Blvd, San Jose, CA 95131 US2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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