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FDA 510(k)

SCOOP 1

K-Number: K981080 · 1998-06-17

ApplicantTranstracheal Systems
Decision Date1998-06-17
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SCOOP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Transtracheal Systems. It received FDA 510(k) clearance on 1998-06-17 under 510(k) number K981080. 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 SCOOP 1?

SCOOP 1 is a medical device that received FDA 510(k) clearance on 1998-06-17. The listed applicant is Transtracheal Systems. The 510(k) number is K981080.

When did SCOOP 1 receive FDA 510(k) clearance?

SCOOP 1 received FDA 510(k) clearance on 1998-06-17, under 510(k) number K981080.

Who is the listed applicant for SCOOP 1?

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

What is the FDA product code for SCOOP 1?

The FDA product code for SCOOP 1 is BTO.

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Other records listing Transtracheal Systems 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.

K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000K981078TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000K962944TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)K904748TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100K904749TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200K902281MODIFIED SCOOP TRANSTRACHEAL CATHETERS

View all 8 devices →

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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