GCLClass II
Esophagoscope, General & Plastic Surgery
Gastroenterology, Urology · 21 CFR 876.1500
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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).
MDR events26All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances4All time
Recent MDR events
26 adverse event reports on file
- PENTAXOct 15, 2025MalfunctionHoya Corporation Pentax Tokyo Office9610877-2025-53632
- PENTAXOct 1, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-57195
- PENTAXSep 25, 2024MalfunctionHoya Corporation Pentax Tokyo Office9610877-2024-57156
- PENTAXNov 28, 2023MalfunctionHoya Corporation Pentax Tokyo Office9610877-2023-61271
- PENTAXApr 18, 2023MalfunctionHoya Corporation Pentax Tokyo Office9610877-2023-53614
- PENTAXOct 26, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-59272
- PENTAXAug 22, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-56807
- PENTAXFeb 28, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-50798
- PENTAXOct 28, 2021MalfunctionHoya Corporation Pentax Tokyo Office9610877-2021-01316
- PENTAXAug 11, 2021MalfunctionHoya Corporation Pentax Tokyo Office9610877-2021-10729
Event type breakdown
Malfunction26
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Pentax Precision Instrument Corp.May 30, 1995
K951197 · FE-24X, FIBER ESOPHAGOSCOPE
- Pentax Precision Instrument Corp.May 30, 1995
K951198 · FE-34TH, FIBER ESOPHAGOSCOPE
- Phx Technologies Corp.Feb 17, 1994
K934510 · 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
- C.R. Bard, Inc.Oct 30, 1992
K922086 · BARD BIOPSY FORCEPS