Home / 510(k) Clearances / K812810

510(k) K812810

PENTAX FLEXIBLE DRIODENOFIBERSCOPE by Pentax Precision Instrument Corp. — Product Code FAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1981
Date Received
October 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panendoscope (Gastroduodenoscope)
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Pentax Precision Instrument Corp.

  • K041395 — EG-3630UR (June 9, 2004)
  • K041397 — EG-3830UT (June 9, 2004)
  • K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (June 9, 2004)
  • K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (August 8, 2003)
  • K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (February 11, 2003)
  • K023376 — EB-1830T3, VIDEO BRONCHOSCOPE (October 16, 2002)
  • K021276 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (September 12, 2002)
  • K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (September 6, 2002)
  • K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (February 4, 2002)
  • K010740 — FG-36UX, FIBER ULTRASOUND GASTROSCOPE (April 17, 2001)

Other clearances for product code FAK

  • K760822 — MODEL TX-8 PANENDOSCOPE (October 21, 1976)