510(k) K242110

PENTAX Medical Video Colonoscope (EC38-i20cWL) by Pentax of America, Inc. — Product Code FDF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 3, 2025
Date Received: July 19, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Colonoscope And Accessories, Flexible/Rigid
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To examine or perform procedures in the colon or rectum 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 at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Pentax of America, Inc.

K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid (December 16, 2025)
K251127 — PENTAX Medical Video Processor (EPK-i8020c) (June 3, 2025)
K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscop (December 6, 2024)
K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (August 1, 2024)
K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (July 24, 2024)
K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB1 (January 18, 2024)
K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use (January 12, 2024)
K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14 (December 1, 2023)
K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope E (July 28, 2023)
K213235 — PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System (December 21, 2022)

Other clearances for product code FDF

K252457 — Disposable Distal End Tape Hood (January 30, 2026)
K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (September 24, 2025)
K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM (May 23, 2025)
K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal (May 15, 2025)
K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
K232922 — Pure-Vu EVS System (October 20, 2023)
K230332 — Ambu® aScope Colon; Ambu® aBox 2 (September 15, 2023)
K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (September 8, 2023)