FDA 510(k)

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

Numéro K : K251256 · 2025-12-16

Date de décision2025-12-16

Code produitFDS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251256. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Pentax of America, Inc.. The 510(k) number is K251256.

When did PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) receive FDA 510(k) clearance?

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251256.

Who is the listed applicant for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

The FDA product code for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is FDS.

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Source officielle

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