Spinaut-P
FDA 510(k) K150915 · Imedicom Co., Ltd.
510(k) numberK150915
Submission
- Device name
- Spinaut-P
- Applicant
- Imedicom Co., Ltd.
Gunpo-Si, KR - Received
- April 6, 2015
- Decision date
- March 18, 2016
- 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 |
|---|---|---|
| K182287 | MEDINAUT PlusHRX · Traditional | 04/06/2019SE |
| K173541 | EpinautBSO · Traditional | 08/24/2018SE |
| K153296 | MEDINAUT Kyphoplasty SystemNDN · Traditional | 07/29/2016SE |
| K151268 | Spinaut-V, Spinaut-S, Spinaut-IHRX · Traditional | 03/16/2016SE |
| K150789 | Spinaut-E, Spinaut-IBSO · Traditional | 03/01/2016SE |
| K133669 | Medinaut Kyphoplasty SystemNDN · Traditional | 04/04/2014SE |
Questions and answers
When was Spinaut-P cleared by the FDA?
Spinaut-P (K150915) received a 510(k) decision of Substantially Equivalent on March 18, 2016, 347 days after the submission was received.
What is the product code of K150915?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.