Endo Keeper
FDA 510(k) K152598 · Nelis
510(k) numberK152598
Submission
- Device name
- Endo Keeper
- Applicant
- Nelis
Bucheon, KR - Received
- September 11, 2015
- Decision date
- March 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTJ – Laparoscopic Single Port Access Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Other 510(k)s with product code OTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232062 | Uni-portOTJ · Traditional | Dalim Medical Corp. | 01/16/2024SE |
| K220081 | Core-SportOTJ · Traditional | Incore Co., Ltd. | 09/28/2022SE |
| K202688 | AFS Medical Sterile Single-Use Access Port SystemOTJ · Traditional | Afs Medical Co. , Ltd. | 10/14/2021SE |
| K160797 | FMX314 Surgical PlatformOTJ · Traditional | Fortimedix Surgical B.V. | 08/26/2016SE |
| K121309 | Asc Quadport + Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 09/06/2012SE |
| K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…OTJ · Traditional | Richard Wolf Medical Instruments Corp. | 08/03/2012SE |
| K111407 | Triport, Triport+, TRIPORT15, QuadportOTJ · Traditional | Advanced Surgical Concepts | 01/18/2012SE |
| K112196 | OctotmportOTJ · Special | Dalim Surgnet Corporation | 09/14/2011SE |
| K110004 | Asc Triport+ Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 01/26/2011SE |
| K101794 | Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport…OTJ · Special | Advanced Surgical Concepts | 11/29/2010SE |
More from Advanced Surgical Concepts
| 510(k) | Device | Decision |
|---|---|---|
| K141715 | Glove PortGCJ · Traditional | 03/25/2015SE |
Questions and answers
When was Endo Keeper cleared by the FDA?
Endo Keeper (K152598) received a 510(k) decision of Substantially Equivalent on March 17, 2016, 188 days after the submission was received.
What is the product code of K152598?
The FDA product code is OTJ – Laparoscopic Single Port Access Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.