Atlas FDA

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

FDA 510(k) clearance K201118 · decided 2020-05-26

Clearance details

K-number
K201118
Device name
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2020-04-27
Decision date
2020-05-26
Days to decision
29 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Pressio 3 Multi-parameter Neuromonitoring System (K252241)Sophysa2026-04-10
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285)Raumedic AG2025-08-29
B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821)Braincare Desenvolvimento E Inovação Tecnológica S.A.2024-07-18
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890)Integra Lifesciences Production Corporation2024-02-04
B4C System (K201989)Braincare Desenvolvimento E Inovacao Tecnologica S.A.2021-10-08
CereLink ICP Monitor (K210993)Integra Lifesciences Production Corporation2021-04-30
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630)Medtronic, Inc.2020-04-09
Becker External Drainage and Monitoring System (K200456)Medtronic, Inc.2020-03-26
BcSs-PICNI-2000 Sensor (K182073)Braincare Desenvolvimento E Inovacao Tecnologica S.A.2019-10-17
CereLink ICP Monitor, CereLink ICP Extension Cable (K183406)Integra Lifesciences Corp.2019-01-11
AURA ICP MONITORING SYSTEM (K172209)Branchpoint Technologies, Inc.2018-05-18
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (K173192)Codman & Shurtleff, Inc.2017-11-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SynchroMed™ Infusion System; Ascenda™ Intrathecal Catheters (P860004/S459)Medtronic, Inc.2026-08-08
Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (P960009/S540)Medtronic, Inc.2026-08-08
Sphere-9 Catheter AFR-00001 (P240013/S030)Medtronic, Inc.2026-08-06
Sphere-9 Catheter and Affera Ablation System (P240013/S029)Medtronic, Inc.2026-08-04
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar (P010015/S589)Medtronic, Inc.2026-07-31
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED (P980035/S846)Medtronic, Inc.2026-07-31
Aurora EV ICD (DVEA3E4) (P220012/S074)Medtronic, Inc.2026-07-31
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S229)Medtronic, Inc.2026-07-31