GYK — Instrument, Shunt System Implantation Class I
FDA product code GYK covers "Instrument, Shunt System Implantation", a Class I medical device regulated under 21 CFR 882.4545. Submissions are reviewed by the Neurology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- GYK
- Device Class
- Class I
- Regulation Number
- 882.4545
- Submission Type
- 510(k) Exempt
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962761 | Cook | REIGEL TUNNELING DEVICE | Oct 11, 1996 |
| K934391 | Radionics | V/P AND L/P CATHETER PASSERS | Nov 19, 1993 |
| K930606 | Pudenz-Schulte Medical Research | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Sep 10, 1993 |
| K932273 | Cordis | CORDIS TUNNELER | Aug 23, 1993 |
| K895868 | Baxter Healthcare | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Oct 31, 1989 |
| K883607 | Codman And Shurtleff | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Sep 30, 1988 |
| K873771 | American V. Mueller | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | Dec 18, 1987 |
| K865075 | Holter-Hausner Intl | H-H SUBGALEAL TROCAR | Jan 13, 1987 |
| K853370 | Holter-Hausner Intl | H-H CATHETER PASSERS(TACL DESIGN | Sep 18, 1985 |
| K853368 | Holter-Hausner Intl | H-H SHUNT INTRODUCER | Sep 6, 1985 |
| K841553 | Holter-Hausner Intl | H-H SHUNT PASSERS | May 14, 1984 |
| K792639 | Holter-Hausner Intl | H-H SHUNT INTRODUCER | Dec 31, 1979 |
| K771529 | Cordis | PERITONEAL INTRODUCER & SHEATH | Aug 16, 1977 |