Product code KGW
- Device name
- Ring (Wound Protector), Drape Retention, Internal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4370
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260982 | 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-r... | Applied Medical Resources Corporation | 2026-04-24 |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | 2026-02-23 |
| K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2013-02-08 |
| K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | Applied Medical Resources Corp. | 2010-04-02 |
| K093296 | ALEXIS LAPAROSCOPIC SYSTEM | Applied Medical Resources Corp. | 2009-11-05 |
| K062907 | ALEXIS WOUND RETRACTOR | Applied Medical Resources | 2007-01-09 |
| K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | 2004-08-26 |
| K840946 | MICROPOROUS HYPOALLERGENIC | Gainor Medical | 1984-08-17 |
| K790306 | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | 1979-02-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20607915139142 | MIGS Kit 1 | APPLIED MEDICAL RESOURCES CORPORATION | 2018-05-09 |
| B5911425L0 | EZ Access™ | V L V ASSOCIATES (INC) | 2017-12-18 |
| B5911425M0 | EZ Access™ | V L V ASSOCIATES (INC) | 2017-12-18 |
| B5911425S0 | EZ Access™ | V L V ASSOCIATES (INC) | 2017-12-18 |
| B5911425XL0 | EZ Access™ | V L V ASSOCIATES (INC) | 2017-12-18 |
| B5911425XS0 | EZ Access™ | V L V ASSOCIATES (INC) | 2017-12-18 |
| 00607915117269 | Alexis O Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117245 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117276 | Alexis O Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117283 | Alexis O Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118105 | Alexis ® O C-Section Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118112 | Alexis ® O C-Section Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118129 | Alexis ® O C-Section Protector - Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118136 | Alexis ® O C-Section Protector - Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915119928 | Alexis Laparoscopic System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915119935 | Alexis Laparoscopic System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915125219 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117252 | Alexis O Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117238 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117221 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117214 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915117207 | Alexis Wound Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915123161 | Alexis ® Orthopaedic Protector | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-23 |
| 00607915123185 | Alexis ® Orthopaedic Protector | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-23 |
| 00607915123192 | Alexis ® Orthopaedic Protector | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-23 |
| 10885380062803 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |
| 10885380064364 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |
| 10885380064357 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |
| 10885380064340 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |
| 10885380064333 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |