Recall Z-1268-2020— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2020-01-03, terminated 2021-01-26. It names one FDA 510(k) clearance: K131855. Product: Pentax Video Colonoscope Model: EC38-i10L. Reason: Distributed in the USA without an approved 510K.
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-03
- Terminated
- 2021-01-26
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Pentax Video Colonoscope Model: EC38-i10L
Reason for recall
Distributed in the USA without an approved 510K
Data sourced from openFDA. This site is unofficial and independent of the FDA.