Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES

K-Number: K962807 · 1997-05-02

ApplicantAmerican Surgical Sponges
Decision Date1997-05-02
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Sponges. It received FDA 510(k) clearance on 1997-05-02 under 510(k) number K962807. 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 SPONGES/NEUROSURGICAL SPONGES?

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES is a medical device that received FDA 510(k) clearance on 1997-05-02. The listed applicant is American Surgical Sponges. The 510(k) number is K962807.

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

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES received FDA 510(k) clearance on 1997-05-02, under 510(k) number K962807.

Who is the listed applicant for AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES?

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

What is the FDA product code for AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES?

The FDA product code for AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES is HBA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)Aesculap

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.

↑