Atlas FDA

Hugo™ RAS System

FDA 510(k) clearance K250725 · decided 2025-12-03

Clearance details

K-number
K250725
Device name
Hugo™ RAS System
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2025-03-10
Decision date
2025-12-03
Days to decision
268 days
Clearance type
Traditional
Product code
SCV
Device class
2
Regulation number
878.4964
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
North Haven, CT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Anovo Surgical System (6Ne) (K260804)Momentis Surgical , Ltd.2026-07-22
Versius Surgical System (Versius Plus) (K252111)Cmr Surgical Limited2025-12-16
Versius Surgical System (DEN230078)Cmr Surgical Limited2024-10-11

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18