Decision Date1984-05-25
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ENDO-JECT is the device name listed in this FDA 510(k) record. The listed applicant is Autovage. It received FDA 510(k) clearance on 1984-05-25 under 510(k) number K840943. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENDO-JECT?
ENDO-JECT is a medical device that received FDA 510(k) clearance on 1984-05-25. The listed applicant is Autovage. The 510(k) number is K840943.
When did ENDO-JECT receive FDA 510(k) clearance?
ENDO-JECT received FDA 510(k) clearance on 1984-05-25, under 510(k) number K840943.
Who is the listed applicant for ENDO-JECT?
The FDA 510(k) record lists Autovage as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENDO-JECT?
The FDA product code for ENDO-JECT is BTR.
Other records listing Autovage 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.
View all 7 devices →
Related Devices (Code: BTR)
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.
K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps
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.