Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Instrument Exit Point on Touch Surgery™ Aide

K-Number: K253984 · 2026-06-04

ApplicantCovidien, LLC
Decision Date2026-06-04
Product CodeSFE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Instrument Exit Point on Touch Surgery™ Aide is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253984. The device is classified under product code SFE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instrument Exit Point on Touch Surgery™ Aide?

Instrument Exit Point on Touch Surgery™ Aide is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Covidien, LLC. The 510(k) number is K253984.

When did Instrument Exit Point on Touch Surgery™ Aide receive FDA 510(k) clearance?

Instrument Exit Point on Touch Surgery™ Aide received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253984.

Who is the listed applicant for Instrument Exit Point on Touch Surgery™ Aide?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument Exit Point on Touch Surgery™ Aide?

The FDA product code for Instrument Exit Point on Touch Surgery™ Aide is SFE.

Other records listing Covidien, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTK251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)K250725Hugo™ RAS SystemK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

View all 119 devices →

Related Devices (Code: SFE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250268HyperSnap Surgical System (HSS)Hypervision Surgical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑