Celestin Pulsion Esophogeal Prosthesis

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K813169 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Deaver T-Drain & Cattel T-Drain

  Class II

  FDA 510(k) K841034 Active Cleared 13 Apr 1984

• Blakemore Tube

  Class II

  FDA 510(k) K841038 Active Cleared 13 Apr 1984

• Rectal Balloon Catheters

  Class II

  FDA 510(k) K841036 Active Cleared 13 Apr 1984

• Cole Tube-Latex

  Class II

  FDA 510(k) K840973 Active Cleared 30 Mar 1984

• Nasopharyngeal Airways

  Class I

  FDA 510(k) K841093 Active Cleared 23 Mar 1984

• Four Lumen Blakemore Tube

  Class II

  FDA 510(k) K832672 Active Cleared 12 Sep 1983

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• What is the purpose of the Celestin Pulsion Esophageal Prosthesis?

  The Celestin Pulsion Esophageal Prosthesis is a self-expanding tubular stent designed to relieve malignant esophageal strictures by maintaining patency of the esophagus, providing mechanical dilation to restore swallowing function in patients with dysphagia due to malignant obstruction.

• How is the Celestin Pulsion Esophageal Prosthesis supplied and what is its sterility status?

  The device is supplied as a single-use, non-sterile prosthesis that requires endoscopic placement under direct visualization. It must be handled with sterile technique during insertion despite being non-sterile.

• What sizes and models are available for the Celestin Pulsion Esophageal Prosthesis?

  The prosthesis is available in a single size as specified in the original submission (K813169). No additional sizes or models are mentioned in the device data.

• What are the storage and handling requirements for this device?

  Storage and handling instructions are detailed in the original submission documentation. The device is not MRI-safe, so it should be kept away from MRI environments.

• What is the regulatory pathway for the Celestin Pulsion Esophageal Prosthesis?

  The device is regulated under FDA 510(k) clearance (Traditional pathway, GU Advisory Committee) with a decision code of SESE, indicating it is substantially equivalent to predicate devices.