YelloPort Elite Port Access System
FDA 510(k) K190592 · Surgical Innovations Limited
510(k) numberK190592
Submission
- Device name
- YelloPort Elite Port Access System
- Applicant
- Surgical Innovations Limited
Leeds, GB - Received
- March 7, 2019
- Decision date
- April 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
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| K210495 | Port Access SystemGCJ · Traditional | 06/18/2021SE |
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| K111986 | Logic Laparoscopic Instrument SystemGEI · Traditional | 01/26/2012SE |
| K100109 | Logiflex Laparoscopic Band Positioning DeviceGCJ · Traditional | 07/15/2010SE |
| K063485 | Logic Laparoscopic ScissorsGEI · Traditional | 12/01/2006SE |
| K955393 | Numo NM-1000 Automatic Carbon-Dioxide for EndoscopeHIF · Traditional | 01/09/1997SE |
| K962193 | Portland TrocarsGCJ · Traditional | 08/28/1996SE |
| K944292 | Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations…OCW · Traditional | 11/15/1994SE |
| K934105 | Dispos/Reusable Surg Skin/Stainless Steel StaplesGAG · Traditional | 03/28/1994SE |
Questions and answers
When was YelloPort Elite Port Access System cleared by the FDA?
YelloPort Elite Port Access System (K190592) received a 510(k) decision of Substantially Equivalent on April 29, 2019, 53 days after the submission was received.
What is the product code of K190592?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.