Pentax Precision Instrument Corp.
Medical device manufacturer in Orangeburg, NY.
67510(k) clearances
0PMA approvals
0recalls
Device types
- FDF Colonoscope And Accessories, Flexible/Rigid 11
- EOQ Bronchoscope (Flexible Or Rigid) 9
- ODG Endoscopic Ultrasound System… 7
- FDS Gastroscope And Accessories, Flexible/Rigid 7
- FAM Sigmoidoscope And Accessories, Flexible/Rigid 6
- ITX Transducer, Ultrasonic, Diagnostic 4
- FBN Choledochoscope And Accessories… 3
- FDT Duodenoscope And Accessories, Flexible/Rigid 3
- GCT Light Source, Endoscope, Xenon Arc 2
- EOB Nasopharyngoscope (Flexible Or Rigid) 2
- CAL Laryngoscope, Non-Rigid 2
- GCL Esophagoscope, General & Plastic Surgery 2
- GDB Endoscope, Fiber Optic 1
- FAK Panendoscope (Gastroduodenoscope) 1
- EQL Laryngostroboscope 1
- FAJ Cystoscope And Accessories, Flexible/Rigid 1
- FGB Ureteroscope And Accessories, Flexible/Rigid 1
- FST Light, Surgical, Fiberoptic 1
- FET Endoscopic Video Imaging System/Component… 1
- FXX Mask, Surgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
| K964815 | AP-4000, Air Pulse Sensory StimulatorLLN · Traditional | 09/04/1997SE |
| K961974 | FG-36UX, Ultrasound Upper Gi FiberscopeITX · Traditional | 02/10/1997SE |
| K963056 | ED-3410, Video DuodenoscopeFDT · Traditional | 10/10/1996SE |
| K962897 | EG-3400, Video GastroscopeFDS · Traditional | 10/04/1996SE |
| K962460 | EG-3800T, Video GastroscopeFDS · Traditional | 09/16/1996SE |
| K961568 | ED-344OTFDT · Traditional | 07/09/1996SE |
| K961564 | EG-2940, Video GastroscopeFDS · Traditional | 07/09/1996SE |
| K961570 | KEC-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)FDF · Traditional | 06/24/1996SE |
| K961567 | ES-3840, Video SigmoidoscopeFAM · Traditional | 06/24/1996SE |
| K961563 | EC-384OTL, Video ColonscopeFDF · Traditional | 06/19/1996SE |
| K951579 | EC-3800TL, Video ColonoscopeFDF · Traditional | 03/21/1996SE |
| K951577 | ES-3800, Video SigmoidoscopeFAM · Traditional | 03/21/1996SE |
| K951574 | EC-3800L, Video ColonoscopeFDF · Traditional | 03/21/1996SE |
| K953876 | Pentax Ultrasound Endoscope Model FG-32UA (Modification)ODG · Traditional | 11/24/1995SE |
| K953286 | FCP-9P, Fiber CholedochoscopeFBN · Traditional | 11/03/1995SE |
| K951576 | FS-34P2, Fiber SigmoidoscopeFAM · Traditional | 06/29/1995SE |
| K951580 | FC-38LH, Fiber ColonosccopeFDF · Traditional | 06/27/1995SE |
| K951578 | FC-38LX, Fiber ColonoscopeFDF · Traditional | 06/27/1995SE |
| K951575 | FC-38TLH, Fiber ColonoscopeFDF · Traditional | 06/27/1995SE |
| K951573 | FS-38H, Fiber SigmoidoscopeFAM · Traditional | 06/27/1995SE |
| K951572 | FS-38X, Fiber SigmoidoscopeFAM · Traditional | 06/27/1995SE |
| K933683 | Pentax Face MaskFXX · Traditional | 06/02/1995SE |
| K951198 | FE-34TH, Fiber EsophagoscopeGCL · Traditional | 05/30/1995SE |
| K951197 | FE-24X, Fiber EsophagoscopeGCL · Traditional | 05/30/1995SE |
| K951191 | FCN-15X, Fiber CholedochonephroscopeFBN · Traditional | 05/30/1995SE |
| K951199 | FB-18X, Fiber BronchoscopeEOQ · Traditional | 04/10/1995SE |
| K951196 | FNL-10P, Fiber NasoparhyngoscopeEOB · Traditional | 04/07/1995SE |
| K951195 | FI-10PCAL · Traditional | 04/06/1995SE |
| K951194 | FI-10MCAL · Traditional | 04/06/1995SE |
| K934918 | EPM-3300 Video ProcessorFET · Traditional | 02/07/1994SE |
| K934920 | VB-1830/VB-1530, Video BronchoscopeEOQ · Traditional | 01/26/1994SE |
| K921315 | Pentax Xenon Light SourceGCT · Traditional | 06/25/1993SE |
| K921707 | Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2EOB · Traditional | 07/01/1992SE |
| K915274 | Metal Halide Light Source Model LM 250FST · Traditional | 01/23/1992SE |
| K914106 | Pentax Ureterorenofiberscope, Model FUR-10PFGB · Traditional | 01/10/1992SE |
| K914008 | Pentax Cystofiberscope, Model FCY-15PFAJ · Traditional | 01/10/1992SE |
| K904573 | Pentax Ultrasound Endoscope, Model FG-32UAODG · Traditional | 06/12/1991SE |
| K850020 | Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23FDS · Traditional | 07/09/1985SE |
| K833924 | Two Channel Gastrofiberscope FG-36TFDS · Traditional | 02/04/1984SE |
| K832492 | Broncho Fiberscope FB-19CEOQ · Traditional | 09/20/1983SE |
| K832449 | Laryngotelescope Curved MLC-1EOQ · Traditional | 09/20/1983SE |
| K832007 | Pentax FG-34JA GastrofiberscopeFDS · Traditional | 08/11/1983SE |
| K832006 | Pentax FD-34A DuodenofiberscopeFDT · Traditional | 08/01/1983SE |
| K822844 | Pentax Bronchofiberscope #FB-19EEOQ · Traditional | 10/26/1982SE |
| K822846 | Pentax FC-38LA & FC-38SA ColonofiberFDF · Traditional | 10/22/1982SE |
| K821974 | Pentax Choledochofiberscope, #FCD-15AFBN · Traditional | 08/10/1982SE |
| K812810 | Pentax Flexible DriodenofiberscopeFAK · Traditional | 11/17/1981SE |
| K811059 | Pentax Bronchofiberscope #FB-15AEOQ · Traditional | 05/27/1981SE |
| K810682 | Pentax Colonoscope Model FC-34LAFDF · Traditional | 04/03/1981SE |
| K810791 | Pentax Colonoscope Model FC-34 MaFDF · Traditional | 03/31/1981SE |
| K810007 | Pentax Upper G.I. Fiberscope, #FG-34GDB · Traditional | 01/15/1981SE |
| K801866 | Pentax Laryngo-Stroboscope Model LS-1AEQL · Traditional | 09/16/1980SE |
| K801223 | Pentex Fexible Colonscope, Mod. FC-34AFDF · Traditional | 06/09/1980SE |
| K792342 | Pentax Brochofiberscope Model FB-17D,EOQ · Traditional | 12/27/1979SE |
| K792267 | Pentex Bronchofiberscope Model FB-17AEOQ · Traditional | 12/19/1979SE |
| K792341 | Pentax Flexible Sigmoidoscope Mod. FS-34FAM · Traditional | 12/10/1979SE |
| K792215 | Pentex Upper G.I. Scope Model FG-28AGCT · Traditional | 12/10/1979SE |