Alexis Laparoscopic System
FDA 510(k) K093296 · Applied Medical Resources Corp.
510(k) numberK093296
Submission
- Device name
- Alexis Laparoscopic System
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- October 21, 2009
- Decision date
- November 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KGW – Ring (Wound Protector), Drape Retention, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…KGW · Special | Applied Medical Resources Corporation | 04/24/2026SE |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…KGW · Traditional | Applied Medical Resources Corporation | 02/23/2026SE |
| K113268 | Alexis O Wound Protector/RetractorKGW · Traditional | Applied Medical Resources Corp. | 02/08/2013SE |
| K100120 | Alexis Orthopaedic Wound RetractorKGW · Traditional | Applied Medical Resources Corp. | 04/02/2010SE |
| K062907 | Alexis Wound RetractorKGW · Traditional | Applied Medical Resources | 01/09/2007SE |
| K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304KGW · Traditional | Applied Medical Resources Corp. | 08/26/2004SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | Gainor Medical | 08/17/1984SE |
| K790306 | Edge Protector, BarrierKGW · Traditional | Surgikos, Inc. | 02/22/1979SE |
More from Surgikos, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…KGW · Special | 04/24/2026SE |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…KGW · Traditional | 02/23/2026SE |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion)GEI · Special | 11/04/2025SE |
| K252442 | Kii Structural Balloon Access SystemGCJ · Traditional | 10/31/2025SE |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI · Traditional | 10/31/2025SE |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | 10/02/2025SE |
| K232880 | Inzii Ripstop Redeployable Retrieval SystemGCJ · Special | 11/01/2023SE |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI · Special | 10/14/2022SE |
| K220969 | GelPOINT V-Path Vaginal Access SystemMOK · Traditional | 09/16/2022SE |
| K211043 | Alexis Contained Extraction SystemGCJ · Traditional | 03/31/2022SE |
Questions and answers
When was Alexis Laparoscopic System cleared by the FDA?
Alexis Laparoscopic System (K093296) received a 510(k) decision of Substantially Equivalent on November 5, 2009, 15 days after the submission was received.
What is the product code of K093296?
The FDA product code is KGW – Ring (Wound Protector), Drape Retention, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.4370.