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FDA 510(k)

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)

K-Number: K112598 · 2013-06-20

ApplicantAmerican Surgical Company, LLC
Decision Date2013-06-20
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Company, LLC. It received FDA 510(k) clearance on 2013-06-20 under 510(k) number K112598. The device is classified under product code HBA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)?

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) is a medical device that received FDA 510(k) clearance on 2013-06-20. The listed applicant is American Surgical Company, LLC. The 510(k) number is K112598.

When did AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) receive FDA 510(k) clearance?

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) received FDA 510(k) clearance on 2013-06-20, under 510(k) number K112598.

Who is the listed applicant for AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)?

The FDA 510(k) record lists American Surgical Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)?

The FDA product code for AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) is HBA.

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Other records listing American Surgical Company, LLC 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.

K121822DELICOT

Related Devices (Code: HBA)

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.

K193346Codman Surgical Patties & StripsIntegra LifeSciences CorporationK121822DELICOTAmerican Surgical Company, LLCK073576NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESHarod Enterprises, Inc.K062406AESCULAP NEURO PATTIESAesculap, Inc.K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)AesculapK020736TRAATEK COTTONOID PATTIESTraatek, 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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