Company ยท US
Pentax Precision Instrument Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2004. Name variants (Inc, Corp, punctuation) are merged.
67510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 11 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 9 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 7 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 7 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 3 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 3 |
| CAL | Laryngoscope, Non-Rigid | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 |
| GCL | Esophagoscope, General & Plastic Surgery | 2 |
| GCT | Light Source, Endoscope, Xenon Arc | 2 |
| EQL | Laryngostroboscope | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FAK | Panendoscope (Gastroduodenoscope) | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| FST | Light, Surgical, Fiberoptic | 1 |
| FXX | Mask, Surgical | 1 |
| GDB | Endoscope, Fiber Optic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2004 | K041397 | EG-3830UT Pentax Precision Instrument Corp. | ITX |
| Jun 9, 2004 | K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ITX |
| Jun 9, 2004 | K041395 | EG-3630UR Pentax Precision Instrument Corp. | ITX |
| Aug 8, 2003 | K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Feb 11, 2003 | K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Oct 16, 2002 | K023376 | EB-1830T3, VIDEO BRONCHOSCOPE Pentax Precision Instrument Corp. | EOQ |
| Sep 12, 2002 | K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Sep 6, 2002 | K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Feb 4, 2002 | K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Apr 17, 2001 | K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE Pentax Precision Instrument Corp. | ODG |
| Sep 4, 1997 | K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR Pentax Precision Instrument Corp. | LLN |
| Feb 10, 1997 | K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE Pentax Precision Instrument Corp. | ITX |
| Oct 10, 1996 | K963056 | ED-3410, VIDEO DUODENOSCOPE Pentax Precision Instrument Corp. | FDT |
| Oct 4, 1996 | K962897 | EG-3400, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Sep 16, 1996 | K962460 | EG-3800T, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Jul 9, 1996 | K961568 | ED-344OT Pentax Precision Instrument Corp. | FDT |
| Jul 9, 1996 | K961564 | EG-2940, VIDEO GASTROSCOPE Pentax Precision Instrument Corp. | FDS |
| Jun 24, 1996 | K961570 | KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) Pentax Precision Instrument Corp. | FDF |
| Jun 24, 1996 | K961567 | ES-3840, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 19, 1996 | K961563 | EC-384OTL, VIDEO COLONSCOPE Pentax Precision Instrument Corp. | FDF |
| Mar 21, 1996 | K951579 | EC-3800TL, VIDEO COLONOSCOPE Pentax Precision Instrument Corp. | FDF |
| Mar 21, 1996 | K951577 | ES-3800, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Mar 21, 1996 | K951574 | EC-3800L, VIDEO COLONOSCOPE Pentax Precision Instrument Corp. | FDF |
| Nov 24, 1995 | K953876 | PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) Pentax Precision Instrument Corp. | ODG |
| Nov 3, 1995 | K953286 | FCP-9P, FIBER CHOLEDOCHOSCOPE Pentax Precision Instrument Corp. | FBN |
| Jun 29, 1995 | K951576 | FS-34P2, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 27, 1995 | K951580 | FC-38LH, FIBER COLONOSCCOPE Pentax Precision Instrument Corp. | FDF |
| Jun 27, 1995 | K951578 | FC-38LX, FIBER COLONOSCOPE Pentax Precision Instrument Corp. | FDF |
| Jun 27, 1995 | K951575 | FC-38TLH, FIBER COLONOSCOPE Pentax Precision Instrument Corp. | FDF |
| Jun 27, 1995 | K951573 | FS-38H, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 27, 1995 | K951572 | FS-38X, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 2, 1995 | K933683 | PENTAX FACE MASK Pentax Precision Instrument Corp. | FXX |
| May 30, 1995 | K951198 | FE-34TH, FIBER ESOPHAGOSCOPE Pentax Precision Instrument Corp. | GCL |
| May 30, 1995 | K951197 | FE-24X, FIBER ESOPHAGOSCOPE Pentax Precision Instrument Corp. | GCL |
| May 30, 1995 | K951191 | FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE Pentax Precision Instrument Corp. | FBN |
| Apr 10, 1995 | K951199 | FB-18X, FIBER BRONCHOSCOPE Pentax Precision Instrument Corp. | EOQ |
| Apr 7, 1995 | K951196 | FNL-10P, FIBER NASOPARHYNGOSCOPE Pentax Precision Instrument Corp. | EOB |
| Apr 6, 1995 | K951195 | FI-10P Pentax Precision Instrument Corp. | CAL |
| Apr 6, 1995 | K951194 | FI-10M Pentax Precision Instrument Corp. | CAL |
| Feb 7, 1994 | K934918 | EPM-3300 VIDEO PROCESSOR Pentax Precision Instrument Corp. | FET |
| Jan 26, 1994 | K934920 | VB-1830/VB-1530, VIDEO BRONCHOSCOPE Pentax Precision Instrument Corp. | EOQ |
| Jun 25, 1993 | K921315 | PENTAX XENON LIGHT SOURCE Pentax Precision Instrument Corp. | GCT |
| Jul 1, 1992 | K921707 | PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 Pentax Precision Instrument Corp. | EOB |
| Jan 23, 1992 | K915274 | METAL HALIDE LIGHT SOURCE MODEL LM 250 Pentax Precision Instrument Corp. | FST |
| Jan 10, 1992 | K914106 | PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P Pentax Precision Instrument Corp. | FGB |
| Jan 10, 1992 | K914008 | PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P Pentax Precision Instrument Corp. | FAJ |
| Jun 12, 1991 | K904573 | PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA Pentax Precision Instrument Corp. | ODG |
| Jul 9, 1985 | K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 Pentax Precision Instrument Corp. | FDS |
| Feb 4, 1984 | K833924 | TWO CHANNEL GASTROFIBERSCOPE FG-36T Pentax Precision Instrument Corp. | FDS |
| Sep 20, 1983 | K832492 | BRONCHO FIBERSCOPE FB-19C Pentax Precision Instrument Corp. | EOQ |
Newest 50 of 67.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||