AED Monopolar Lap Accessories
FDA 510(k) K081503 · National Advanced Endoscopy Devices, Inc.
510(k) numberK081503
Submission
- Device name
- AED Monopolar Lap Accessories
- Applicant
- National Advanced Endoscopy Devices, Inc.
Canoga Park, CA, US - Received
- May 29, 2008
- Decision date
- September 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K170285 | AED SinuscopeEOB · Traditional | 08/01/2017SE |
| K141515 | AED Hysteroscope and AccessoriesHIH · Traditional | 01/07/2015SE |
| K102663 | AED ResectoscopeFJL · Traditional | 12/30/2010SE |
| K081553 | AED Bipolar Forceps, Model 13-1646GEI · Traditional | 09/29/2008SE |
| K993689 | AED CystoscopeFAJ · Traditional | 12/15/1999SE |
| K993688 | AED LaparoscopeGCJ · Traditional | 12/06/1999SE |
| K991656 | AED ArthroscopeHRX · Traditional | 12/02/1999SE |
Questions and answers
When was AED Monopolar Lap Accessories cleared by the FDA?
AED Monopolar Lap Accessories (K081503) received a 510(k) decision of Substantially Equivalent on September 25, 2008, 119 days after the submission was received.
What is the product code of K081503?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.