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FDA 510(k)

KAPP BARI-RING, MODEL KS-BR-2005

K-Number: K050384 · 2006-01-13

ApplicantKapp Surgical Instrument, Inc.
Decision Date2006-01-13
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KAPP BARI-RING, MODEL KS-BR-2005 is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K050384. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPP BARI-RING, MODEL KS-BR-2005?

KAPP BARI-RING, MODEL KS-BR-2005 is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K050384.

When did KAPP BARI-RING, MODEL KS-BR-2005 receive FDA 510(k) clearance?

KAPP BARI-RING, MODEL KS-BR-2005 received FDA 510(k) clearance on 2006-01-13, under 510(k) number K050384.

Who is the listed applicant for KAPP BARI-RING, MODEL KS-BR-2005?

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

What is the FDA product code for KAPP BARI-RING, MODEL KS-BR-2005?

The FDA product code for KAPP BARI-RING, MODEL KS-BR-2005 is NEU.

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Other records listing Kapp Surgical Instrument, 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.

K200289Michler-Kapp Cardiovascular Vent CatheterK072216KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005K050657MONDEAL CONTOUR HO SYSTEMK033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANTK030237KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

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Related Devices (Code: NEU)

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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, 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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