FEAClass I
Attachment, Teaching, For Endoscope
Gastroenterology, Urology · 21 CFR 876.1500
MDR events64All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances2All time
Recent MDR events
64 adverse event reports on file
- PENTAXMay 28, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-51186
- PENTAXJan 15, 2026MalfunctionHoya Corporation Pentax Tokyo Office9610877-2026-50125
- PENTAXDec 10, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-54288
- PENTAXOct 2, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-53511
- PENTAXOct 1, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-53510
- PENTAXAug 7, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-52857
- PENTAXJun 10, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-52184
- PENTAXJun 10, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-52193
- PENTAXMar 7, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-51268
- PENTAXMar 5, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-51249
Event type breakdown
Malfunction64
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Teleflex Medical Llc
Morrisville, NC, US
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Teleflex Llc (nadc)
Olive Branch, MS, US
Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Onehalf Design Co.,ltd
Jinan Shandong, CN
510(k) clearances
2 clearances for this product code