FDA product code KGW: Ring (Wound Protector), Drape Retention, Internal
KGW is the FDA product code for ring (wound protector), drape retention, internal. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under KGW, 2 in the last five years, from 5 different applicants. The average 510(k) review took 114 days (median 77); 66 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Ring (Wound Protector), Drape Retention, Internal |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KGW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 2 | 66 |
Compare with all 510(k) review times · Search every KGW clearance
Top KGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources Corp. | 4 | 2013-02-08 |
| Applied Medical Resources Corporation | 2 | 2026-04-24 |
| Applied Medical Resources | 1 | 2007-01-09 |
| Gainor Medical | 1 | 1984-08-17 |
| Surgikos, Inc. | 1 | 1979-02-22 |
Most recent KGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260982 | Applied Medical Resources Corporation | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | 2026-04-24 | 30 |
| K253531 | Applied Medical Resources Corporation | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | 2026-02-23 | 102 |
| K113268 | Applied Medical Resources Corp. | ALEXIS O WOUND PROTECTOR/RETRACTOR | 2013-02-08 | 462 |
| K100120 | Applied Medical Resources Corp. | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | 2010-04-02 | 77 |
| K093296 | Applied Medical Resources Corp. | ALEXIS LAPAROSCOPIC SYSTEM | 2009-11-05 | 15 |
Recalls for KGW devices
openFDA lists no recalls for product code KGW.
Frequently asked questions
What is FDA product code KGW?
KGW is the FDA product code for ring (wound protector), drape retention, internal. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel.
What device class is KGW?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGW?
Across 9 cleared submissions the average was 114 days from receipt to decision (median 77).
Which companies have the most KGW clearances?
Applied Medical Resources Corp. (4); Applied Medical Resources Corporation (2); Applied Medical Resources (1); Gainor Medical (1); Surgikos, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KGW
- Run a recall and safety report across every KGW manufacturer
- Watch product code KGW 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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