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FDA 510(k)

DELICOT

K-Number: K121822 · 2012-09-10

ApplicantAmerican Surgical Company, LLC
Decision Date2012-09-10
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DELICOT 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 2012-09-10 under 510(k) number K121822. 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 DELICOT?

DELICOT is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is American Surgical Company, LLC. The 510(k) number is K121822.

When did DELICOT receive FDA 510(k) clearance?

DELICOT received FDA 510(k) clearance on 2012-09-10, under 510(k) number K121822.

Who is the listed applicant for DELICOT?

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 DELICOT?

The FDA product code for DELICOT 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.

K112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)

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 CorporationK112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American 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

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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