Adapter, Resectoscope

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

510(k) Number

K760174 ↗

FDA Product Code

FDC

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Telescope, Rigid Endoscope

  Class II

  FDA 510(k) K760177 Active Cleared 30 Aug 1976

• Bougie, Filiform, Jackson

  Class I

  FDA 510(k) K770959 Active Cleared 14 Jun 1977

• Pfister-Schwartz Stone Retriever

  Class II

  FDA 510(k) K771302 Active Cleared 2 Aug 1977

• Scissor - 1.5mm Probe Point, Angled

  Class I

  FDA 510(k) K760792 Active Cleared 11 Nov 1976

• Teflon Coated Resectoscope Sheath

  Class II

  FDA 510(k) K761242 Active Cleared 16 Dec 1976

• Converse Altar Retractor

  Class I

  FDA 510(k) K760851 Active Cleared 10 Mar 1977

See all devices from V. Mueller O.V. Baxter Healthcare Corp. →

• What is the resectoscope adapter used for in medical procedures?

  The resectoscope adapter serves as a connector or interface component to attach accessories like biopsy forceps or cutting loops to a resectoscope. This enables precise endoscopic procedures in gastroenterology and urology, facilitating minimally invasive surgical interventions where compatibility between the resectoscope and additional tools is essential.

• Is the resectoscope adapter reusable or single-use?

  The resectoscope adapter is supplied as a reusable medical device. It is intended for use in sterile operating environments, meaning it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality.

• What regulatory pathway was followed for this adapter?

  The adapter follows the traditional 510(k) clearance pathway and was determined to be *Substantially Equivalent* (SESE) by the FDA’s Gastroenterology/Urology advisory committee. This classification means it meets the same performance standards as a legally marketed predicate device.

• Are there specific storage or handling instructions for this adapter?

  No additional storage or handling instructions beyond standard medical device protocols are specified for this adapter. It should be stored in a clean, dry environment and handled according to general medical device care guidelines to maintain sterility and functionality.

• What types of procedures is this adapter compatible with?

  The adapter is designed for compatibility with endoscopic procedures in gastroenterology and urology, particularly those involving a resectoscope. This includes interventions where precise attachment of accessories like biopsy tools or cutting loops is required, such as polypectomies or tissue resections.