510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Pentax Precision Instrument Corp.

Orangeburg, NY, US

Pentax Precision Instrument Corp. appears in FDA device records in Orangeburg, NY. FDA records list 67 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
67
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 67

FDA records hold 67 510(k) clearances for Pentax Precision Instrument Corp. between 1979 and 2004. The busiest year on record is 1995, with 16. The most recent is 2004, with 3.

Clearances by year, as a table
510(k) clearance decisions for Pentax Precision Instrument Corp., by decision year
YearClearances
19794
19802
19815
19823
19834
19841
19851
19911
19924
19931
19942
199516
199611
19972
20011
20024
20032
20043
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K041397EG-3830UTITXSubstantially Equivalent
K041396FG-36UX FIBER ULTRASOUND GASTROSCOPEITXSubstantially Equivalent
K041395EG-3630URITXSubstantially Equivalent
K031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEODGSubstantially Equivalent
K023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEODGSubstantially Equivalent
K023376EB-1830T3, VIDEO BRONCHOSCOPEEOQSubstantially Equivalent
K021276FG-36UX FIBER ULTRASOUND GASTROSCOPEODGSubstantially Equivalent
K021278EG-3630UR, ULTRASOUND VIDEO GASTROSCOPEODGSubstantially Equivalent
K013640EG-3630UR, ULTRASUND VIDEO GASTROSCOPEFDSSubstantially Equivalent
K010740FG-36UX, FIBER ULTRASOUND GASTROSCOPEODGSubstantially Equivalent
K964815AP-4000, AIR PULSE SENSORY STIMULATORLLNSubstantially Equivalent
K961974FG-36UX, ULTRASOUND UPPER GI FIBERSCOPEITXSubstantially Equivalent
K963056ED-3410, VIDEO DUODENOSCOPEFDTSubstantially Equivalent
K962897EG-3400, VIDEO GASTROSCOPEFDSSubstantially Equivalent
K962460EG-3800T, VIDEO GASTROSCOPEFDSSubstantially Equivalent
K961568ED-344OTFDTSubstantially Equivalent
K961564EG-2940, VIDEO GASTROSCOPEFDSSubstantially Equivalent
K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)FDFSubstantially Equivalent
K961567ES-3840, VIDEO SIGMOIDOSCOPEFAMSubstantially Equivalent
K961563EC-384OTL, VIDEO COLONSCOPEFDFSubstantially Equivalent
K951579EC-3800TL, VIDEO COLONOSCOPEFDFSubstantially Equivalent
K951577ES-3800, VIDEO SIGMOIDOSCOPEFAMSubstantially Equivalent
K951574EC-3800L, VIDEO COLONOSCOPEFDFSubstantially Equivalent
K953876PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)ODGSubstantially Equivalent
K953286FCP-9P, FIBER CHOLEDOCHOSCOPEFBNSubstantially Equivalent
K951576FS-34P2, FIBER SIGMOIDOSCOPEFAMSubstantially Equivalent
K951580FC-38LH, FIBER COLONOSCCOPEFDFSubstantially Equivalent
K951578FC-38LX, FIBER COLONOSCOPEFDFSubstantially Equivalent
K951575FC-38TLH, FIBER COLONOSCOPEFDFSubstantially Equivalent
K951573FS-38H, FIBER SIGMOIDOSCOPEFAMSubstantially Equivalent
K951572FS-38X, FIBER SIGMOIDOSCOPEFAMSubstantially Equivalent
K933683PENTAX FACE MASKFXXSubstantially Equivalent
K951198FE-34TH, FIBER ESOPHAGOSCOPEGCLSubstantially Equivalent
K951197FE-24X, FIBER ESOPHAGOSCOPEGCLSubstantially Equivalent
K951191FCN-15X, FIBER CHOLEDOCHONEPHROSCOPEFBNSubstantially Equivalent
K951199FB-18X, FIBER BRONCHOSCOPEEOQSubstantially Equivalent
K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOBSubstantially Equivalent
K951195FI-10PCALSubstantially Equivalent
K951194FI-10MCALSubstantially Equivalent
K934918EPM-3300 VIDEO PROCESSORFETSubstantially Equivalent
K934920VB-1830/VB-1530, VIDEO BRONCHOSCOPEEOQSubstantially Equivalent
K921315PENTAX XENON LIGHT SOURCEGCTSubstantially Equivalent
K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOBSubstantially Equivalent
K915274METAL HALIDE LIGHT SOURCE MODEL LM 250FSTSubstantially Equivalent
K914106PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10PFGBSubstantially Equivalent
K914008PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PFAJSubstantially Equivalent
K904573PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UAODGSubstantially Equivalent
K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23FDSSubstantially Equivalent
K833924TWO CHANNEL GASTROFIBERSCOPE FG-36TFDSSubstantially Equivalent
K832492BRONCHO FIBERSCOPE FB-19CEOQSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Pentax Precision Instrument Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Pentax Precision Instrument Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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