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FDA 510(k)

Universal Seal (5-12 mm)

K-Number: K261249 · 2026-07-14

ApplicantIntuitive Surgical, Inc.
Decision Date2026-07-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Universal Seal (5-12 mm) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261249. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universal Seal (5-12 mm)?

Universal Seal (5-12 mm) is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K261249.

When did Universal Seal (5-12 mm) receive FDA 510(k) clearance?

Universal Seal (5-12 mm) received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261249.

Who is the listed applicant for Universal Seal (5-12 mm)?

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

What is the FDA product code for Universal Seal (5-12 mm)?

The FDA product code for Universal Seal (5-12 mm) is GCJ.

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Other records listing Intuitive Surgical, Inc. 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.

K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorK251739da Vinci Surgical System (IS5000)K251763IRISeg

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Related Devices (Code: GCJ)

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.

K261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.K253994TroKit Laparoscope Lens WiperTroCare, LLCK252532Inno-Port Disposable Bladed TrocarTaiwan Surgical CorporationK2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.

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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