coaptech.comPUMA-G Pediatric System
Coaptech, Inc.
Coapt LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010605876 | 3010605876 | Coapt LLC | 1 | N | 2026-01-01 | 303 W. Institute Pl. Suite 200 Chicago IL US 60610 |
| 3015177732 | 3015177732 | CoapTech, Inc. | 1 | N | 2026-01-01 | 101 W. Dickman Street, Suite 700 Baltimore MD US 21230 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850026037029 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037036 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Safety PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037043 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Standard PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00850026037050 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Standard PUSH PEG Kit) | 1 443 574 6934 | info@coaptech.com |
| 00860312001504 | PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemBalloon Catheter | 1 443 574 6934 | info@coaptech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222924 | 1168456978 | K242211 | PUMA-G Pediatric System | KGC | 2025-04-29 |
| 222924 | 1808418125 | K223916 | PUMA-G System | KGC | 2023-03-29 |
| 164499 | 1244943277 | K223605 | ControlSeal Electrode (ELSB) | GXY | 2022-12-30 |
| 164499 | 1505526475 | K191083 | COMPLETE CONTROL System Gen2 | GXY | 2019-05-24 |
| 164499 | 1876426838 | K190416 | Dome Electrode | GXY | 2019-04-04 |
| 222924 | 2016303327 | K183057 | PUMA-G System | KGC | 2019-04-10 |
| 164499 | 1215220765 | K162891 | Complete Control System | GXY | 2017-04-14 |
| 164499 | 1035453081 |
Product Codes Associated With Registrations#
PMN#
PUMA-G System
Coaptech, Inc.
Alpha Control Liner System (ACLS)
Coapt
ControlSeal Electrode (ELSB)
Coapt
COMPLETE CONTROL System Gen2
Coapt, LLC
PUMA-G System
CoapTech LLC
Dome Electrode
Coapt, LLC
Complete Control System
COAPT, LLC
VF LIQUIGEL
COAPT SYSTEMS, INC.
MODIFICATION TO VF GEL PLUS
COAPT SYSTEMS, INC.
VF GEL PLUS
COAPT SYSTEMS, INC.
ULTRATINE FOREHEAD
COAPT SYSTEMS, INC.
ULTRATINE TRANSBLEPH
COAPT SYSTEMS, INC.
MODIFICATION TO ENDOTINE RIBBON
COAPT SYSTEMS, INC.
ENDOTINE RIBBON
COAPT SYSTEMS, INC.
ENDOTINE RIBBON
COAPT SYSTEMS, INC.
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
COAPT SYSTEMS, INC.
ENDOTINE MIDFACE B 4.5 DEVICE
COAPT SYSTEMS, INC.
ENDOTINE FOREHEAD TRIPLE DEVICE
COAPT SYSTEMS, INC.
ENDOTINE TRANSBLEPH DEVICE
COAPT SYSTEMS, INC.
COAPT ENDOTINE CHIN 3.5 DEVICE
COAPT SYSTEMS, INC.
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
COAPT SYSTEMS, INC.
ENDOTINE FOREHEAD DEVICE
COAPT SYSTEMS, INC.
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
Coapt Systems, Inc.
COAPT SYSTMES ENDOTINE DEVICE
COAPT SYSTEMS, INC.
GUDID#
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Safety PUSH PEG Kit)
2023-07-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemBalloon Catheter
2023-07-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Standard PUSH PEG Kit)
2023-12-15
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit without Drape and Standard PUSH PEG Kit)
2023-07-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit)
2023-12-15
PUMA-G System™ - External Magnet in Case
2024-05-16
PUMA-G Pediatric System™ - 80% Offset External Magnet in Case
2025-12-23
PUMA-G Pediatric System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
2025-12-23
PUMA-G Pediatric System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemEssentials Kit
2025-12-23
PUMA-G Pediatric System™ - 80% Offset External Magnet in Case
2025-12-23
Gen2 System Kit - The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome Electrodes (DI=B618E0).
2019-06-19
COMPLETE CONTROL System Gen2 - The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses.
2019-06-12
Complete Controller - Pattern Recognition Processing Unit
2018-05-08
Complete Communicator - PC-Side Wireless Radio Receiver Unit
2018-05-08
Complete Co-Amp - 8-Channel EMG Front End Processing Unit
2018-05-08
Complete Calibrate - Socket-Mount Calibration Unit
2018-05-08
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemGuidewire
2024-10-29
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemGuidewire with Pull Feature
2024-10-29
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire
2024-10-29
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire with Pull Feature
2024-10-29
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemBalloon Catheter
2024-02-13
PUMA-G System™ - External Magnet in Case
2024-05-16
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
2024-05-16
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemEssentials Kit
2024-05-16
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) SystemFull Procedural Kit (Convenience Kit and PUSH PEG Kit)
2024-05-09
PUMA-G System™ - External Magnet in Case
2023-07-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
2024-02-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape and Standard PUSH PEG Kit)
2023-12-15
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit)
2023-12-15
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
Dome Electrodes - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2019-04-15
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
2023-07-13
PUMA-G System™ - Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Drape and Standard PUSH PEG Kit)
2023-07-13
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20