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FDA 510(k)

HOOD TRACHEAL STOMA BUTTON

K-Number: K882430 · 1988-06-28

ApplicantHood Laboratories
Decision Date1988-06-28
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOOD TRACHEAL STOMA BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Hood Laboratories. It received FDA 510(k) clearance on 1988-06-28 under 510(k) number K882430. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOOD TRACHEAL STOMA BUTTON?

HOOD TRACHEAL STOMA BUTTON is a medical device that received FDA 510(k) clearance on 1988-06-28. The listed applicant is Hood Laboratories. The 510(k) number is K882430.

When did HOOD TRACHEAL STOMA BUTTON receive FDA 510(k) clearance?

HOOD TRACHEAL STOMA BUTTON received FDA 510(k) clearance on 1988-06-28, under 510(k) number K882430.

Who is the listed applicant for HOOD TRACHEAL STOMA BUTTON?

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

What is the FDA product code for HOOD TRACHEAL STOMA BUTTON?

The FDA product code for HOOD TRACHEAL STOMA BUTTON is BTO.

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Other records listing Hood Laboratories 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.

K921452ACOUSTIC RHINOMETERK920994HOOD NASAL SEPTAL BUTTONK905703KRUPIN EYE VALVE WITH DISKK904821ELIACHAR MODIFIED ESOPHAGEAL STENTK897049GIBSON ENDOLYMPHATIC SHUNTK897059HOOD SPEAKING VALVE

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Related Devices (Code: BTO)

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.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

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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