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)

FIXATION DEVICE, TRACH TUBE

K-Number: K882694 · 1988-08-15

ApplicantBioseal
Decision Date1988-08-15
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FIXATION DEVICE, TRACH TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1988-08-15 under 510(k) number K882694. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATION DEVICE, TRACH TUBE?

FIXATION DEVICE, TRACH TUBE is a medical device that received FDA 510(k) clearance on 1988-08-15. The listed applicant is Bioseal. The 510(k) number is K882694.

When did FIXATION DEVICE, TRACH TUBE receive FDA 510(k) clearance?

FIXATION DEVICE, TRACH TUBE received FDA 510(k) clearance on 1988-08-15, under 510(k) number K882694.

Who is the listed applicant for FIXATION DEVICE, TRACH TUBE?

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

What is the FDA product code for FIXATION DEVICE, TRACH TUBE?

The FDA product code for FIXATION DEVICE, TRACH TUBE is CBH.

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

Other records listing Bioseal 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.

K893814SURGICAL INSTRUMENT KIT, DISPOSABLEK882695RUBBER BAND, STERILEK882696DERMICEL, MONTGOMERY STRAPK882710INTESTINAL SPONGESK882711GAUZE SPONGE 12PLYK882712STICK SPONGE

View all 10 devices →

Related Devices (Code: CBH)

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.

K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.K950930TRACHE-TITEThe Varner Group, Inc.K950318FLEX BLUEKing Systems Corp.K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.

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.

↑