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FDA 510(k)

MONO-SWIFT

K-Number: K030786 · 2003-05-06

ApplicantCp Medical
Decision Date2003-05-06
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONO-SWIFT is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K030786. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONO-SWIFT?

MONO-SWIFT is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Cp Medical. The 510(k) number is K030786.

When did MONO-SWIFT receive FDA 510(k) clearance?

MONO-SWIFT received FDA 510(k) clearance on 2003-05-06, under 510(k) number K030786.

Who is the listed applicant for MONO-SWIFT?

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

What is the FDA product code for MONO-SWIFT?

The FDA product code for MONO-SWIFT is NEW.

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 Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

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Related Devices (Code: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, 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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