FDA 510(k)

PENTAX Medical Video Colonoscope (EC38-i20cWL)

K-Nummer: K242110 · 2025-01-03

Entscheidungsdatum2025-01-03

ProduktcodeFDF

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

PENTAX Medical Video Colonoscope (EC38-i20cWL) 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 2025-01-03 under 510(k) number K242110. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the PENTAX Medical Video Colonoscope (EC38-i20cWL)?

PENTAX Medical Video Colonoscope (EC38-i20cWL) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Pentax of America, Inc.. The 510(k) number is K242110.

When did PENTAX Medical Video Colonoscope (EC38-i20cWL) receive FDA 510(k) clearance?

PENTAX Medical Video Colonoscope (EC38-i20cWL) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K242110.

Who is the listed applicant for PENTAX Medical Video Colonoscope (EC38-i20cWL)?

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 Colonoscope (EC38-i20cWL)?

The FDA product code for PENTAX Medical Video Colonoscope (EC38-i20cWL) is FDF.

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Weitere Einträge mit Pentax of America, Inc. als Antragsteller

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Verwandte Geräte (Code: FDF)

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

Offizielle Quelle

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