510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921315Substantially Equivalent

Pentax Xenon Light Source

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

K921315 is the FDA 510(k) clearance record for PENTAX XENON LIGHT SOURCE, a class II device, cleared for Pentax Precision Instrument Corp. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 67 510(k) clearances for Pentax Precision Instrument Corp., from to . As of , FDA records show no recalls naming K921315.

Clearance record

Decision date
Received
(464 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax Precision Instrument Corp. 30 Ramland Rd., Orangeburg NY
510(k) summary
Statement
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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