510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210485Substantially Equivalent

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

PENTAX of America, Inc., Montvale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210485 is the FDA 510(k) clearance record for PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family), a class II device, cleared for Pentax of America, Inc. on under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid). FDA's definition for product code FDS reads: "To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available...". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show 2 recalls naming K210485.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FDS Gastroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax of America, Inc. 3 Paragon Dr.,, Montvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDS

Trailing 12 months
8 clearances under product code FDS in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FDS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20263
September 20261
October 20260