Devoro Medical, Inc.

FDA Regulatory Profile

Devoro Medical, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Dec 8, 2022 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on May 29, 2024.

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Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2022Fremont, CADevicesNo Action Indicated (NAI)3015614177

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660May 29, 2024
K221391WOLF Thrombectomy™ SmartClaw CatheterNov 10, 2022
K210911WOLF Thrombectomy System, 14FOct 19, 2021
K210530WOLF Thrombectomy System, 6FAug 27, 2021
K200101WOLF Thrombectomy V SystemApr 27, 2020