Meditron Automatic Electronic Insuff. Model AEI-15
FDA 510(k) K920071 · Medical Devices, Inc.
510(k) numberK920071
Submission
- Device name
- Meditron Automatic Electronic Insuff. Model AEI-15
- Applicant
- Medical Devices, Inc.
Hackensack, NJ, US - Received
- January 7, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K131719 | Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional | 10/30/2013SE |
| K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602MKJ · Traditional | 02/05/2001SE |
| K930084 | Micro-ArthroscopeHRX · Traditional | 09/01/1995SN |
| K943126 | ElectroflexGXY · Traditional | 12/05/1994SE |
| K940012 | Smartbrace ElectrodeGXY · Traditional | 12/05/1994SE |
| K935132 | Home Microcurrent HMCGZJ · Traditional | 03/14/1994SE |
| K934619 | FlexmateGZJ · Traditional | 02/23/1994SE |
| K924897 | Xenon Endoscopic Illuminator, Model XEI-300GCT · Traditional | 07/06/1993SE |
| K930053 | Video Camera W/ Electronic Shutter Model VCE-10FWF · Traditional | 05/17/1993SE |
| K923914 | If-Ii (TM), Model 7200IPF · Traditional | 11/06/1992SE |
Questions and answers
When was Meditron Automatic Electronic Insuff. Model AEI-15 cleared by the FDA?
Meditron Automatic Electronic Insuff. Model AEI-15 (K920071) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 196 days after the submission was received.
What is the product code of K920071?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.