Busse Epidural Catheter

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

510(k) Number

K070465 ↗

FDA Product Code

BSO

Device Class

Class II

Regulation

21 CFR Part 868.5120

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Busse Plastic Tubing Connectors and Accessories

  Class I

  FDA 510(k) K935835 Active Cleared 12 Jan 1994

• Dressing Change Tray

  Class II

  FDA 510(k) K952334 Active Cleared 14 Jul 1995

• Busse Epidural Catheter Kit

  Class II

  FDA 510(k) K093920 Active Cleared 6 Aug 2010

• Infectious Disease Protection Kit, Disposable

  Class II

  FDA 510(k) K874306 Active Cleared 22 Mar 1988

• Busse Umbilical Cord Clamp Cutter

  Class II

  FDA 510(k) K021055 Active Cleared 29 Apr 2002

• J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula

  Class II

  FDA 510(k) K110883 Active Cleared 8 Jun 2011

See all devices from Busse Hospital Disposables →

• What clinical settings is the Busse Epidural Catheter designed for use in, and how is it typically utilized there?

  The Busse Epidural Catheter is designed for use in clinical settings such as operating rooms, labor and delivery units, and intensive care units. It is intended for insertion into the epidural space to deliver local anesthetics or therapeutic agents for pain management or surgical anesthesia, ensuring controlled anesthesia during procedures or continuous pain relief for patients.

• Is the Busse Epidural Catheter intended for single-use or reusable applications, and what does this mean for its sterility?

  The Busse Epidural Catheter is explicitly supplied as a single-use device, meaning it is intended for one-time use only. This design ensures sterility is maintained throughout its intended lifespan, reducing the risk of infection or contamination associated with reuse.

• What regulatory pathway was followed for the approval of the Busse Epidural Catheter, and what does this indicate about its safety and equivalence?

  The Busse Epidural Catheter was cleared through the FDA’s 510(k) pathway, specifically under the classification for epidural analgesia or anesthesia (regulation number 868.5120). The clearance type is labeled as ‘Traditional,’ and it was determined to be *substantially equivalent* to predicate devices, meaning it meets the same performance standards and safety requirements as previously approved catheters in this category.

• Are there multiple sizes or models of the Busse Epidural Catheter, and if so, how might this affect its selection for a patient?

  The data lists multiple FEI (Final Establishment Identification) numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the Busse Epidural Catheter is described as a *conduction catheter* without explicit size variations mentioned. Clinicians should refer to the manufacturer’s packaging or documentation for specific sizing details, as these are not detailed in the provided regulatory data.