Karl Storz Monopolar Coagulation Needle, Loop Electrodes
by Karl Storz Endoscopy-America, Inc.
510(k) K944793
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944793 | Date24 Jan 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4160
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Coagulator-Cutter, Endoscopic, Unipolar (and Accessories), designed for monopolar coagulation procedures. It employs high-frequency electrical current to cut, coagulate, or fulgurate tissue during endoscopic applications, including obstetrics and gynecology. The needle and loop electrodes are intended for precise tissue manipulation in minimally invasive surgical settings.
The Karl Storz Monopolar Coagulation Needle and Loop Electrodes are supplied as single-use, sterile instruments for endoscopic use. They are classified as Class II devices under FDA regulation 884.4160 and were granted FDA 510(k) clearance (K944793) as substantially equivalent to a predicate device. These electrodes are intended for use in controlled surgical environments, adhering to standard endoscopic protocols.