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FDA 510(k)

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER

K-Number: K012955 · 2001-10-22

ApplicantBioform, Inc.
Decision Date2001-10-22
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Bioform, Inc.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012955. 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 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER?

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Bioform, Inc.. The 510(k) number is K012955.

When did COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER receive FDA 510(k) clearance?

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012955.

Who is the listed applicant for COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER?

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

What is the FDA product code for COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER?

The FDA product code for COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER is NEU.

Related Clinical Trials

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Other records listing Bioform, 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.

K033398LARYNGEAL AUGMENTATION IMPLANTK030682CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1

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

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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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