510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812810Substantially Equivalent

Pentax Flexible Driodenofiberscope

Pentax Precision Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812810 is the FDA 510(k) clearance record for PENTAX FLEXIBLE DRIODENOFIBERSCOPE, a class II device, cleared for Pentax Precision Instrument Corp. on under FDA product code FAK (Panendoscope (Gastroduodenoscope)). FDA's definition for product code FAK reads: "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...". FDA records list 67 510(k) clearances for Pentax Precision Instrument Corp., from to . As of , FDA records show no recalls naming K812810.

Clearance record

Decision date
Received
(42 days to decision)
Product code
FAK Panendoscope (Gastroduodenoscope)
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax Precision Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FAK

Trailing 12 months

FDA records hold no clearances under product code FAK in the trailing twelve months.

FDA records show no clearances under product code FAK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260