FDA product code LYU: Accessory, Surgical Apparel
LYU is the FDA product code for accessory, surgical apparel. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 56 510(k) submissions under LYU, from 43 different applicants. The average 510(k) review took 181 days (median 130). FDA has posted 9 recalls for LYU devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessory, Surgical Apparel |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LYU clearance
Top LYU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Armor Corp. | 5 | 1993-05-07 |
| Sloan Corp. | 3 | 1996-03-19 |
| Wells Lamont Corp. | 3 | 1995-04-10 |
| Instrument Makar, Inc. | 2 | 1997-02-25 |
| Derekduck Industries Corp. | 2 | 1994-09-26 |
38 more applicants have LYU clearances. See the full list in Caduvo.
Most recent LYU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011755 | Stryker Corp. | STRYKER T4 HYTREL (R) TOGAS | 2001-06-22 | 16 |
| K965237 | Copioumed Intl., Inc. | NURSES BOUFFANT CAP | 1997-08-27 | 239 |
| K970988 | Far East Science & Technology Development Co., Ltd. | FAR-EAST BOUFFANT CAPS | 1997-07-10 | 114 |
| K964364 | Instrument Makar, Inc. | DISPOSABLE APRON | 1997-02-25 | 116 |
| K961791 | Depuy, Inc. | DEPUY DISPOSABLE FILTER/HOOD | 1996-08-09 | 92 |
Recalls for LYU devices
9 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-05-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 6 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LYU?
LYU is the FDA product code for accessory, surgical apparel. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is LYU?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYU?
Across 56 cleared submissions the average was 181 days from receipt to decision (median 130).
Which companies have the most LYU clearances?
Medical Armor Corp. (5); Sloan Corp. (3); Wells Lamont Corp. (3); Instrument Makar, Inc. (2); Derekduck Industries Corp. (2).
Have LYU devices been recalled?
Yes: 9 product recalls across 4 recall events; the most recent began 2023-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LYU
- Run a recall and safety report across every LYU manufacturer
- Watch product code LYU 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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