FDA product code GYK: Instrument, Shunt System Implantation
GYK is the FDA product code for instrument, shunt system implantation. It is a Class I device, regulated under 21 CFR 882.4545 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under GYK, from 8 different applicants. The average 510(k) review took 58 days (median 37). FDA has posted 1 recall for GYK devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Shunt System Implantation |
| Device class | Class I |
| Regulation | 21 CFR 882.4545 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GYK clearance
Top GYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Holter-Hausner Intl. | 5 | 1987-01-13 |
| Cordis Corp. | 2 | 1993-08-23 |
| Cook, Inc. | 1 | 1996-10-11 |
| Radionics, Inc. | 1 | 1993-11-19 |
| Pudenz-Schulte Medical Research Corp. | 1 | 1993-09-10 |
3 more applicants have GYK clearances. See the full list in Caduvo.
Most recent GYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962761 | Cook, Inc. | REIGEL TUNNELING DEVICE | 1996-10-11 | 87 |
| K934391 | Radionics, Inc. | V/P AND L/P CATHETER PASSERS | 1993-11-19 | 71 |
| K930606 | Pudenz-Schulte Medical Research Corp. | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | 1993-09-10 | 217 |
| K932273 | Cordis Corp. | CORDIS TUNNELER | 1993-08-23 | 102 |
| K895868 | Baxter Healthcare Corp | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | 1989-10-31 | 27 |
Recalls for GYK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-22.
Frequently asked questions
What is FDA product code GYK?
GYK is the FDA product code for instrument, shunt system implantation. It is a Class I device, regulated under 21 CFR 882.4545 and reviewed by the Neurology panel.
What device class is GYK?
Class I, regulation 21 CFR 882.4545. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GYK?
Across 13 cleared submissions the average was 58 days from receipt to decision (median 37).
Which companies have the most GYK clearances?
Holter-Hausner Intl. (5); Cordis Corp. (2); Cook, Inc. (1); Radionics, Inc. (1); Pudenz-Schulte Medical Research Corp. (1).
Have GYK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GYK
- Run a recall and safety report across every GYK manufacturer
- Watch product code GYK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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