FDA product code EYT: Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
EYT is the FDA product code for sheath, corrugated rubber, for nonindwelling catheter, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under EYT, from 4 different applicants. The average 510(k) review took 106 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top EYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kit Pak, Inc. | 1 | 1994-05-18 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 1 | 1994-04-11 |
| Sierra Laboratories, Inc. | 1 | 1988-08-02 |
| Cook Urological, Inc. | 1 | 1988-08-02 |
Most recent EYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934080 | Kit Pak, Inc. | URINARY DRAINAGE BAG | 1994-05-18 | 271 |
| K935774 | Kendall Healthcare Products Co. Div.Of Tyco Health | CURITY FAST-CATH FEMALE CATHETER KIT | 1994-04-11 | 129 |
| K883057 | Sierra Laboratories, Inc. | COMFORT CATH MALE EXTERNAL CATHETER | 1988-08-02 | 14 |
| K883119 | Cook Urological, Inc. | VPI NON-ADHESIVE CONDOM CATHETER | 1988-08-02 | 8 |
Recalls for EYT devices
openFDA lists no recalls for product code EYT.
Frequently asked questions
What is FDA product code EYT?
EYT is the FDA product code for sheath, corrugated rubber, for nonindwelling catheter, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is EYT?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EYT?
Across 4 cleared submissions the average was 106 days from receipt to decision (median 72).
Which companies have the most EYT clearances?
Kit Pak, Inc. (1); Kendall Healthcare Products Co. Div.Of Tyco Health (1); Sierra Laboratories, Inc. (1); Cook Urological, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EYT
- Run a recall and safety report across every EYT manufacturer
- Watch product code EYT 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.
All Gastroenterology and Urology product codes · FDA product code lookup