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FDA 510(k)

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)

K-Number: K240881 · 2024-11-01

ApplicantCovidien (Part of Medtronic)
Decision Date2024-11-01
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien (Part of Medtronic). It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K240881. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)?

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Covidien (Part of Medtronic). The 510(k) number is K240881.

When did Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) receive FDA 510(k) clearance?

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K240881.

Who is the listed applicant for Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)?

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

What is the FDA product code for Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)?

The FDA product code for Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) is GAG.

Related Clinical Trials

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.

NCT07351071Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal ResectionsRECRUITING

Other records listing Covidien (Part of Medtronic) 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.

K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

Related Devices (Code: GAG)

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)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien

Official Source

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

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