Single Stick Radially Expanding Dilator

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

510(k) Number

K943056 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Innerdyne Step Trocar Expandable Port, S.T.E.P.

  Class II

  FDA 510(k) K943253 Active Cleared 11 Oct 1994

• Innerdyne Medical Laparoscopic Sphincterotomy Kit

  Class II

  FDA 510(k) K932692 Active Cleared 27 Dec 1993

• Innerdyne Single-Stick Radially Expanding Dilator

  Class II

  FDA 510(k) K940428 Active Cleared 25 Apr 1994

• Intherm Radially Expanding Dilating Introducer

  Class II

  FDA 510(k) K931489 Active Cleared 15 Oct 1993

• Innerdyne Step Trocar Expandable Port, S.T.E.P.

  Class II

  FDA 510(k) K940232 Active Cleared 18 Apr 1994

• What types of medical procedures is this dilator designed to assist with, and in which specialties would it be used?

  The Single Stick Radially Expanding Dilator is specifically designed to gradually dilate strictures or narrow passages in the body, making it useful for procedures requiring controlled widening of tracts. It is intended for use in gastroenterology (e.g., esophageal or biliary strictures) and urology (e.g., urethral or ureteral strictures), where access for diagnostic or therapeutic tools must be established. Clinicians in these specialties rely on this device to safely prepare passages before inserting endoscopes, catheters, or other instruments.

• Is this dilator meant for single-use only, and if so, how should it be handled to maintain sterility?

  Yes, the Single Stick Radially Expanding Dilator is supplied as a single-use instrument, meaning it is intended for one-time use only to ensure patient safety and sterility. Since it is designed for sterile procedures, it must be handled with aseptic techniques—opening the packaging only in a controlled environment (e.g., operating room or procedure suite) and using it immediately after removal. Discard it after use to prevent contamination or reuse.

• How was the FDA clearance for this device determined, and what does ‘substantially equivalent’ mean in this context?

  The device received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent, Same Essential Features). This means the FDA determined that the Single Stick Radially Expanding Dilator has the same intended use and technological characteristics as a predicate device already on the market, ensuring it meets safety and effectiveness standards without requiring a full clinical trial. The clearance was granted in 1994, confirming compliance with U.S. medical device regulations.

• Are there different sizes or models available for this dilator, and if so, how would a clinician determine the appropriate one for a patient?

  The provided data does not specify individual sizes or models for the Single Stick Radially Expanding Dilator, but such variations are common in dilators to accommodate different anatomical strictures (e.g., esophageal vs. urethral). Clinicians would typically select the appropriate size based on pre-procedure imaging or measurements (e.g., endoscopy, cystoscopy, or radiographic studies) to match the diameter of the targeted stricture. Consulting the manufacturer’s instructions or product catalog would provide exact sizing details for clinical application.