Jesberg Esophagoscopes W/Austinetic S S

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K760652 ↗

FDA Product Code

EOX

Device Class

Class II

Regulation

21 CFR Part 874.4710

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Pilling Identiloops

  Not classified

  FDA 510(k) K854914 Active Cleared 24 Jan 1986

• Pilling Laparoscopic Instrumentation

  Class II

  FDA 510(k) K934427 Active Cleared 10 Jan 1994

• Arterial Graft Sizers

  Not classified

  FDA 510(k) K761141 Active Cleared 6 Jan 1977

• Frazier Suction Instrument-Dispos

  Class I

  FDA 510(k) K832636 Active Cleared 14 Oct 1983

• Fiberbronchoscope (Pentax Fb-17A)

  Class II

  FDA 510(k) K760171 Active Cleared 19 Jul 1976

• Laser Bronchoscope System

  Class II

  FDA 510(k) K861921 Active Cleared 2 Jun 1986

See all devices from Pilling Co. →

• Are these esophagoscopes intended for single-use or can they be reused in clinical settings?

  The Jesberg Esophagoscopes with Austinetic S S are explicitly designed as reusable medical devices for clinical use by trained healthcare professionals. Since they are not described as single-use, they must be properly cleaned, disinfected, and sterilized between procedures to maintain safety and functionality.

• How do I determine the size of a Jesberg Esophagoscope model I’m considering?

  The sizes of the Jesberg Esophagoscopes are indicated by their model reference codes, which are not detailed in the provided data. You would need to consult the manufacturer’s documentation or catalog for specific measurements (e.g., diameter, length) associated with each model number.

• Are these esophagoscopes pre-sterilized when packaged, or do I need to sterilize them myself?

  The Jesberg Esophagoscopes are not specified as sterile upon packaging, meaning they are not pre-sterilized. Since they are reusable, they must be sterilized by the facility before first use and after each procedure to ensure patient safety.

• What is the regulatory pathway for these esophagoscopes, and which advisory committee was involved?

  The Jesberg Esophagoscopes with Austinetic S S were cleared through the FDA’s 510(k) process under the Ear, Nose, and Throat (EN) advisory committee. They are classified under FDA regulation 874.4710 and were granted clearance in 1976 as substantially equivalent to a predicate device.

• Are there multiple models available, and how can I identify which one fits my clinical needs?

  Multiple models of the Jesberg Esophagoscopes exist, as indicated by the various registration numbers and FEI numbers listed (e.g., 3005465238, 3003782610). While the exact specifications (e.g., length, tip angle) aren’t provided here, the model reference codes likely correspond to different sizes or configurations. Contacting the manufacturer, Pilling Co., would help match a model to your specific diagnostic or therapeutic requirements.