510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951197Substantially Equivalent

Fe-24X, Fiber Esophagoscope

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

K951197 is the FDA 510(k) clearance record for FE-24X, FIBER ESOPHAGOSCOPE, a class II device, cleared for Pentax Precision Instrument Corp. on under FDA product code GCL (Esophagoscope, General & Plastic Surgery). FDA's definition for product code GCL 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 K951197.

Clearance record

Decision date
Received
(75 days to decision)
Product code
GCL Esophagoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax Precision Instrument Corp. 3117 Commerce Pkwy., Miramar FL
510(k) summary
Summary
Third party review
No

Clearances, product code GCL

Trailing 12 months

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

FDA records show no clearances under product code GCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCL, 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