510(k) K161853
- Device
- ProGAV Programmable Shunt System, ProGAV 2.0 Adjustable Shunt System, ProSA Adjustable Shunt System
- Applicant
- AESCULAP INC.
- 510(k) number
- K161853
- Product code
- JXG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-27
- Date received
- 2016-07-06
- Regulation
- 882.5550
- Classification name
- Shunt, Central Nervous System And Components
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHY A. RACOSKY
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers#
- 1219114
- 1720929
- 1722746
- 3017636737
- 9617601
- 3016678045
- 2648988
- 2029275
- 2024024
- 9611827
- 3007544634
- 3003418325
- 3028006458
- 9610612
- 1220477
- 2523553
- 3003542872
- 3030733800
- 3014334038
- 3003477135
- 1450662
- 3033728927
- 9611274
- 9612164
- 2916714
- 3004056227
- 3014522419
- 3006611221
- 1422634
- 3001587388
- 2530808
- 2023988
- 3008102042
- 3016577622
- 3015865915
- 8043817
- 3031571464
- 3015531529
- 3014507028
- 3006697299
- 3010408671
- 3008791915
- 3006240422
- 1836324
- 3012507533
- 2953359
- 3043513133
- 3015151147
- 3008114965
- 2030624
- 2032112
- 9612501
- 3018094310
- 1047843
- 2011171
- 3008087383
- 3004530184
- 3024673
- 1721983
- 3007156625
- 3013944123
- 3012421607
- 3015462837
- 3013557562
- 3004593495
- 3013886523
- 1221051
- 3011689956
- 3004721439
Source Documents#
Other 510(k) Records For Product Code JXG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251598 | Intellidrop | Brainspace, Inc. | 2025-12-10 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | 2025-11-28 |
| K252514 | EVAC-MRI | Phasor Health, LLC | 2025-11-05 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025-08-08 |
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra Lifesciences Production Corporation | 2025-08-06 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | 2025-06-20 |
| K243205 | EVAC | Phasor Health, LLC | 2025-06-03 |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2025-03-10 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | 2024-12-16 |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | 2024-08-20 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation | 2024-01-17 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | 2023-12-19 |
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | 2023-10-19 |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | 2023-02-09 |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | 2023-02-02 |
Legacy Summary#
summary
FDA Review#
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