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FDA 510(k)

AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)

K-Number: K031008 · 2003-05-09

ApplicantAesculap
Decision Date2003-05-09
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap. It received FDA 510(k) clearance on 2003-05-09 under 510(k) number K031008. 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 AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)?

AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) is a medical device that received FDA 510(k) clearance on 2003-05-09. The listed applicant is Aesculap. The 510(k) number is K031008.

When did AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) receive FDA 510(k) clearance?

AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) received FDA 510(k) clearance on 2003-05-09, under 510(k) number K031008.

Who is the listed applicant for AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)?

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

What is the FDA product code for AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)?

The FDA product code for AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) is HBA.

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Other records listing Aesculap 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.

K093649AESCULAP STERILCONTAINER SK062085S4 SPINAL SYSTEMK062510AESCULAP STERILCONTAINER SYSTEMK061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019K043079BICONTACT HIP SYSTEM WITH U-CAPK040865AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

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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, LLCK121822DELICOTAmerican Surgical Company, LLCK073576NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESHarod Enterprises, Inc.K062406AESCULAP NEURO PATTIESAesculap, Inc.K020736TRAATEK 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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