Disposable Fiberoptic Endoilluminator

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

Full name

Gamp & Associates Disposable Fiberoptic Endoilluminator

510(k) Number

K952586 ↗

FDA Product Code

MPA

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gamp & Associates Disposable Endoilluminator W/Pick

  Class II

  FDA 510(k) K952584 Active Cleared 1 Sep 1995

• Gamp & Assoc. Disposable Endoocular Laser Probe

  Class II

  FDA 510(k) K954307 Active Cleared 22 Dec 1995

• Gamp & Associates Disposable Fiberoptic Viscoinjector

  Class II

  FDA 510(k) K952581 Active Cleared 5 Jan 1996

• Gamp & Associates Disposable Bare End Fiber

  Class II

  FDA 510(k) K952580 Active Cleared 1 Sep 1995

• Gamp & Assoc. Disposable Ill Endocular Laser Probe

  Class II

  FDA 510(k) K954306 Active Cleared 22 Dec 1995

• Gamp & Assoc. Disposable Aspirating Endoocular Laser Probe

  Class II

  FDA 510(k) K954308 Active Cleared 22 Dec 1995

See all devices from Gamp & Assoc. →

• What clinical specialties is this endoilluminator primarily used in, and why is it designed for single-use?

  This disposable fiberoptic endoilluminator is primarily used in gastroenterology and urology procedures, as indicated by its regulatory classification under product code MPA and advisory committee focus on these specialties. It is designed for single-use only to eliminate the need for sterilization, reducing infection risks and ensuring consistent performance in endoscopic examinations. This aligns with standard endoscopic practice guidelines for disposable devices.

• How is this device supplied, and are there multiple sizes or models available?

  The device is supplied as a disposable unit, meaning each unit is intended for one-time use. While the regulatory data lists multiple FEI numbers (e.g., 3000215205, 1000117501), these are manufacturer-specific identifiers rather than distinct size or model specifications. No explicit size variations or model differences are described in the provided data, so it appears as a standardized disposable design.

• Does this endoilluminator require any special handling or storage conditions?

  Since it is a disposable, single-use device, no sterilization is required. However, standard sterile packaging is implied for clinical use. Storage should follow general medical device guidelines—keep in a cool, dry place, away from direct sunlight or extreme temperatures, to preserve functionality until use. The lack of MRI safety information also suggests it should not be exposed to magnetic fields.

• What regulatory pathway was followed for FDA clearance, and how does that affect its use?

  The device received FDA 510(k) clearance (K952586) under the traditional pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. safety and performance standards for Class II medical devices (product code MPA). Clinically, this means it meets FDA requirements for use in gastroenterology and urology procedures, but users should always follow the manufacturer’s instructions for proper handling and disposal.