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
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962761 | cook | REIGEL TUNNELING DEVICE | October 11, 1996 |
| K934391 | radionics | V/P AND L/P CATHETER PASSERS | November 19, 1993 |
| K930606 | pudenz-schulte medical research | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | September 10, 1993 |
| K932273 | cordis | CORDIS TUNNELER | August 23, 1993 |
| K895868 | baxter healthcare | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | October 31, 1989 |
| K883607 | codman and shurtleff | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | September 30, 1988 |
| K873771 | american v. mueller | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | December 18, 1987 |
| K865075 | holter-hausner intl | H-H SUBGALEAL TROCAR | January 13, 1987 |
| K853370 | holter-hausner intl | H-H CATHETER PASSERS(TACL DESIGN | September 18, 1985 |
| K853368 | holter-hausner intl | H-H SHUNT INTRODUCER | September 6, 1985 |
| K841553 | holter-hausner intl | H-H SHUNT PASSERS | May 14, 1984 |
| K792639 | holter-hausner intl | H-H SHUNT INTRODUCER | December 31, 1979 |
| K771529 | cordis | PERITONEAL INTRODUCER & SHEATH | August 16, 1977 |