PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family— 510(k) K191282
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K191282 for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family, Substantially Equivalent on 2019-11-08. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code PEA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code PEA
view all- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
- K190805 — PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
- K160275 — Fuse Endoscopic System with FuseBox Processor
More clearances from Pentax of America, Inc.
view all- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
Adverse events under product code PEA
product code PEA- Malfunction
- 515
- Total
- 515
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.