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FDA 510(k)

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

K-Number: K221629 · 2023-02-22

ApplicantCovidien
Decision Date2023-02-22
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221629. 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 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Covidien. The 510(k) number is K221629.

When did Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) receive FDA 510(k) clearance?

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221629.

Who is the listed applicant for Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

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

What is the FDA product code for Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

The FDA product code for Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) 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 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)K253984Instrument Exit Point on Touch Surgery™ AideK253030Capnostream™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 System

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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.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)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.

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.

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