Instrument Exit Point on Touch Surgery Aide
FDA 510(k) K253984 · Covidien, LLC
510(k) numberK253984
Submission
- Device name
- Instrument Exit Point on Touch Surgery Aide
- Applicant
- Covidien, LLC
Mansfield, MA, US - Received
- December 12, 2025
- Decision date
- June 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SFE – Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
Other 510(k)s with product code SFE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250268 | HyperSnap Surgical System (HSS)SFE · Traditional | Hypervision Surgical | 06/24/2025SE |
More from Hypervision Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | 08/13/2026SE |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0…GAG · Traditional | 07/01/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | 05/01/2026SE |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | 12/29/2025SE |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional | 12/29/2025SE |
| K250725 | Hugo RAS SystemSCV · Traditional | 12/03/2025SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | 09/25/2025SE |
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | 12/03/2024SE |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)FLL · Traditional | 08/20/2024SE |
Questions and answers
When was Instrument Exit Point on Touch Surgery Aide cleared by the FDA?
Instrument Exit Point on Touch Surgery Aide (K253984) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 174 days after the submission was received.
What is the product code of K253984?
The FDA product code is SFE – Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation, a Class II (moderate risk) device regulated under 21 CFR 876.1500.