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FDA 510(k)

PERIPATCH ENDO-SLEEVE

K-Number: K063556 · 2007-03-20

ApplicantPm Devices, Inc.
Decision Date2007-03-20
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERIPATCH ENDO-SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Pm Devices, Inc.. It received FDA 510(k) clearance on 2007-03-20 under 510(k) number K063556. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPATCH ENDO-SLEEVE?

PERIPATCH ENDO-SLEEVE is a medical device that received FDA 510(k) clearance on 2007-03-20. The listed applicant is Pm Devices, Inc.. The 510(k) number is K063556.

When did PERIPATCH ENDO-SLEEVE receive FDA 510(k) clearance?

PERIPATCH ENDO-SLEEVE received FDA 510(k) clearance on 2007-03-20, under 510(k) number K063556.

Who is the listed applicant for PERIPATCH ENDO-SLEEVE?

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

What is the FDA product code for PERIPATCH ENDO-SLEEVE?

The FDA product code for PERIPATCH ENDO-SLEEVE is FTM.

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.

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Other records listing Pm Devices, 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.

K040835PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16K033985PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10K031948PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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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