Product code GYK
- Device name
- Instrument, Shunt System Implantation
- Medical specialty
- Neurology
- Device class
- 1
- Regulation number
- 882.4545
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962761 | REIGEL TUNNELING DEVICE | Cook, Inc. | 1996-10-11 |
| K934391 | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | 1993-11-19 |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | 1993-09-10 |
| K932273 | CORDIS TUNNELER | Cordis Corp. | 1993-08-23 |
| K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Baxter Healthcare Corp | 1989-10-31 |
| K883607 | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Codman & Shurtleff, Inc. | 1988-09-30 |
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | American V. Mueller | 1987-12-18 |
| K865075 | H-H SUBGALEAL TROCAR | Holter-Hausner Intl. | 1987-01-13 |
| K853370 | H-H CATHETER PASSERS(TACL DESIGN | Holter-Hausner Intl. | 1985-09-18 |
| K853368 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | 1985-09-06 |
| K841553 | H-H SHUNT PASSERS | Holter-Hausner Intl. | 1984-05-14 |
| K792639 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | 1979-12-31 |
| K771529 | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | 1977-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780537410 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780537403 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 10381780537397 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-05-29 |
| 03760124131451 | Sophysa | SOPHYSA | 2023-06-02 |
| 04041906505608 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505530 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505547 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505554 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505561 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505578 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505585 | AESCULAP | Aesculap AG | 2023-04-03 |
| 04041906505592 | AESCULAP | Aesculap AG | 2023-04-03 |
| 00382830057332 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-17 |
| 00382830057325 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-17 |
| 00382830054119 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830058179 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830055208 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830054140 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830053624 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 10381780521419 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780521402 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780521396 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10866614000181 | Subcutaneous Guidewire - Medium | ARKIS BIOSCIENCES INC. | 2018-12-14 |
| 10381780033172 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-09-01 |
| 10381780034421 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-09-01 |
| 10381780034414 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-09-01 |
| 10381780034391 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-09-01 |
| 10381780033202 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-09-01 |
| 10381780072379 | Integra® | Integra Lifesciences Corporation | 2015-09-22 |
| 10381780072362 | Integra® | Integra Lifesciences Corporation | 2015-09-22 |