Perforated Baskets

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

510(k) Number

K231291 ↗

FDA Product Code

KCT

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Suction and Irrigation Tubes

  Class II

  FDA 510(k) K940960 Active Cleared 8 Nov 1994

• Needle, Spray

  Class II

  FDA 510(k) K770710 Active Cleared 26 Apr 1977

• Trocars Trotec with Automatic Protective Mechanism

  Class II

  FDA 510(k) K003164 Active Cleared 8 Jan 2001

• Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories

  Class II

  FDA 510(k) K042523 Active Cleared 18 Mar 2005

• Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector

  Class II

  FDA 510(k) K972927 Active Cleared 6 Nov 1997

• Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

  Class II

  FDA 510(k) K051176 Active Cleared 5 Oct 2005

See all devices from Richard Wolf Medical Instruments Corp. →

• Are these baskets meant for single-use or can they be reused in a clinical setting?

  These Perforated Baskets (3300 Series) are explicitly designed as a reusable system for flexible endoscopes. Their durable construction and floating storage mechanism are engineered to withstand repeated use, including low-temperature sterilization cycles, ensuring long-term reliability in hospital environments.

• How do these baskets protect endoscopes during sterilization, storage, and transport?

  The baskets feature a perforated design to allow sterilization media to circulate while shielding delicate endoscope components from physical damage. Their floating storage mechanism reduces vibrations during handling, and the robust construction prevents deformation or wear that could compromise the endoscope’s integrity during sterilization, storage, or transport.

• What types of flexible endoscopes are compatible with these baskets, and are there size-specific models?

  The Perforated Baskets 3300 Series are designed for a wide range of flexible endoscopes, though exact compatibility depends on the manufacturer’s specifications for each endoscope model. While the series name (3300) suggests a unified design, the floating mechanism and perforated structure imply adaptability to common endoscope diameters. For precise sizing, refer to Richard Wolf’s documentation or consult their technical support, as no specific models or measurements are listed in the provided data.

• Do these baskets require any special handling or storage conditions?

  The baskets are reusable and intended for hospital use, so they should be cleaned and sterilized according to standard protocols for reusable medical devices. No specific storage conditions (e.g., temperature, humidity) are mentioned in the data, but their durable construction suggests they can be stored in a clean, dry environment when not in use. Always follow manufacturer guidelines for maintenance to ensure longevity and performance.

• What was the regulatory pathway for FDA clearance of these baskets, and how does that affect their use?

  These baskets received FDA 510(k) clearance under K231291, classified under product code KCT (General Hospital Products) with a Substantially Equivalent (SESE) determination by the General Hospital (HO) Advisory Committee. This means they were deemed comparable to a legally marketed predicate device, ensuring compliance with FDA standards for reusable protective containers in hospital settings. The clearance does not imply any specific clinical indication but confirms their safety and effectiveness for the intended use as described.