Recall Z-0510-2020— Applied Medical Resources Corp
Class II · Terminated
Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2018-12-12, terminated 2021-01-22. It names one FDA 510(k) clearance: K171701. Product: GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.. Reason: Unintentional shifting of the tip insulation of the firm's electrosurgical probes..
- Recalling firm
- Applied Medical Resources Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-12
- Terminated
- 2021-01-22
- Firm location
- Rancho Santa Margarita, CA, 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
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Reason for recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.