Kendall Curity 20 Gauge Continuous Epidual Anesthe
by Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) K930219
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930219 | Date27 Apr 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BSO
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5120
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Kendall Curity 20 Gauge Continuous Epidural Anesthesia Catheter is a conduction catheter designed for the administration of local anesthetics during epidural anesthesia procedures. It facilitates continuous infusion of anesthetic agents to maintain prolonged pain relief or anesthesia, commonly used in surgical and obstetric settings.
This device is intended for single-use and is classified as a Class II medical device under FDA regulations (868.5120). Supplied sterile, it is used in clinical environments where epidural anesthesia is administered, such as operating rooms and labor and delivery units. The catheter’s 20-gauge size is standardized for compatibility with epidural needles and injection systems. FDA clearance (K930219) was granted under a 510(k) submission, with the device reviewed by the Anesthesiology Advisory Committee.
Other devices from Kendall Healthcare Products Co. Div.Of Tyco Health
See all devices from Kendall Healthcare Products Co. Div.Of Tyco Health →
Questions
AI-generated answers, 1 Oct 2026
What is the Kendall Curity 20 Gauge Continuous Epidural Anesthesia Catheter used for?
This catheter is specifically designed for administering local anesthetics during epidural anesthesia procedures. It allows for continuous infusion of anesthetic agents, providing prolonged pain relief or anesthesia, which is particularly useful in surgical settings and obstetrics, such as labor and delivery.
Is the Kendall Curity 20 Gauge Continuous Epidural Anesthesia Catheter sterile?
Yes, the catheter is supplied sterile, ensuring it is ready for immediate use in clinical environments where aseptic conditions are critical, such as operating rooms and labor and delivery units.
What gauge size is the catheter, and why is this important?
The catheter is a 20-gauge size, which is standardized for compatibility with epidural needles and injection systems. This gauge size balances flexibility and durability, allowing for effective anesthetic delivery while minimizing patient discomfort during insertion.
Is the Kendall Curity 20 Gauge Continuous Epidural Anesthesia Catheter intended for single-use or reuse?
The catheter is intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for procedures involving direct access to the body’s nervous system.
How should the Kendall Curity 20 Gauge Continuous Epidural Anesthesia Catheter be stored?
The catheter should be stored in its original, unopened packaging in a clean, dry place, away from direct sunlight and extreme temperatures. Proper storage preserves sterility and ensures the catheter remains functional until use.