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FDA 510(k)

SCALPFIX CLIP SYSTEM

K-Number: K012219 · 2001-07-31

ApplicantAesculap, Inc.
Decision Date2001-07-31
Product CodeHBO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCALPFIX CLIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K012219. The device is classified under product code HBO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCALPFIX CLIP SYSTEM?

SCALPFIX CLIP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Aesculap, Inc.. The 510(k) number is K012219.

When did SCALPFIX CLIP SYSTEM receive FDA 510(k) clearance?

SCALPFIX CLIP SYSTEM received FDA 510(k) clearance on 2001-07-31, under 510(k) number K012219.

Who is the listed applicant for SCALPFIX CLIP SYSTEM?

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

What is the FDA product code for SCALPFIX CLIP SYSTEM?

The FDA product code for SCALPFIX CLIP SYSTEM is HBO.

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Other records listing Aesculap, 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.

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Related Devices (Code: HBO)

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.

K253814Raney Clips KitBeijing Honghugaoxiang Science and Technology Development COK050044MEDTRONIC CLIP GUN KITMedtronic NeurosurgeryK033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05Rudolf Storz GmbHK944311ACRA-CUTAcra Cut, Inc.K905433CODMAN DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.K896723CLIP GUN WITH RANEY TYPE SCALP CLIPSOmni Medical Designs

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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