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FDA 510(k)

GripTract-GI Endoscopic Tissue Manipulator

K-Number: K231254 · 2023-11-03

ApplicantActuated Medical, Inc.
Decision Date2023-11-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GripTract-GI Endoscopic Tissue Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231254. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GripTract-GI Endoscopic Tissue Manipulator?

GripTract-GI Endoscopic Tissue Manipulator is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K231254.

When did GripTract-GI Endoscopic Tissue Manipulator receive FDA 510(k) clearance?

GripTract-GI Endoscopic Tissue Manipulator received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231254.

Who is the listed applicant for GripTract-GI Endoscopic Tissue Manipulator?

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

What is the FDA product code for GripTract-GI Endoscopic Tissue Manipulator?

The FDA product code for GripTract-GI Endoscopic Tissue Manipulator is FDF.

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.

NCT06015607Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the ColonRECRUITING

Other records listing Actuated Medical, 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.

K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsK220890IO Needle Safety SheathK200646TubeClear SystemK172556TubeClear SystemK163092TubeClear Control Box and Clearing Stem

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Related Devices (Code: FDF)

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.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

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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