FDA product code EYQ: Garment, Protective, For Incontinence
EYQ is the FDA product code for garment, protective, for incontinence. It is a Class I device, regulated under 21 CFR 876.5920 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 56 510(k) submissions under EYQ, from 28 different applicants. The average 510(k) review took 71 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Garment, Protective, For Incontinence |
| Device class | Class I |
| Regulation | 21 CFR 876.5920 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EYQ clearance
Top EYQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Procter & Gamble Mfg. Co. | 6 | 1988-01-19 |
| Weyerhaeuser Co. | 5 | 1989-01-30 |
| Intera Corp. | 4 | 1989-05-31 |
| Convatec, A Division of E.R. Squibb & Sons | 4 | 1986-11-19 |
| Ipco Corp. | 4 | 1984-07-19 |
23 more applicants have EYQ clearances. See the full list in Caduvo.
Most recent EYQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950784 | Advanced Bioresearch Assoc. | DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM | 1995-05-03 | 71 |
| K932310 | Kit Pak, Inc. | KIT PAK INCONTINENT SKIN CARE KIT | 1994-06-01 | 386 |
| K903342 | Biological Resistance, Inc. | DEODORIZING AND SOUND MUFFLING ANAL PAD | 1990-10-23 | 90 |
| K891686 | Intera Corp. | LIB SYSTEM, BABY/ADULT DIAPER | 1989-05-31 | 70 |
| K885185 | Intera Corp. | INTERA SHIELD AND INTERA UNDERGARMENT | 1989-02-08 | 56 |
Recalls for EYQ devices
openFDA lists no recalls for product code EYQ.
Frequently asked questions
What is FDA product code EYQ?
EYQ is the FDA product code for garment, protective, for incontinence. It is a Class I device, regulated under 21 CFR 876.5920 and reviewed by the Gastroenterology and Urology panel.
What device class is EYQ?
Class I, regulation 21 CFR 876.5920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EYQ?
Across 56 cleared submissions the average was 71 days from receipt to decision (median 53).
Which companies have the most EYQ clearances?
Procter & Gamble Mfg. Co. (6); Weyerhaeuser Co. (5); Intera Corp. (4); Convatec, A Division of E.R. Squibb & Sons (4); Ipco Corp. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code EYQ
- Run a recall and safety report across every EYQ manufacturer
- Watch product code EYQ 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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