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FDA 510(k)

PATCHASSIST

K-Number: K101218 · 2010-06-17

ApplicantPolytouch Medical, Ltd.
Decision Date2010-06-17
Product CodeORQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PATCHASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Polytouch Medical, Ltd.. It received FDA 510(k) clearance on 2010-06-17 under 510(k) number K101218. The device is classified under product code ORQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATCHASSIST?

PATCHASSIST is a medical device that received FDA 510(k) clearance on 2010-06-17. The listed applicant is Polytouch Medical, Ltd.. The 510(k) number is K101218.

When did PATCHASSIST receive FDA 510(k) clearance?

PATCHASSIST received FDA 510(k) clearance on 2010-06-17, under 510(k) number K101218.

Who is the listed applicant for PATCHASSIST?

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

What is the FDA product code for PATCHASSIST?

The FDA product code for PATCHASSIST is ORQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Polytouch Medical, Ltd. 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.

K103269PATCHASSIST LARGE

Related Devices (Code: ORQ)

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.

K250395BioBrace ® RC Delivery SystemConmed CorporationK130782ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK123066ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK121139ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK103269PATCHASSIST LARGEPolytouch Medical, 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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