Reprocessed Endoscopic Electrodes
FDA 510(k) K012685 · Sterilmed, Inc.
Submission
- Device name
- Reprocessed Endoscopic Electrodes
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- August 14, 2001
- Decision date
- February 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLW – Electrode, Electrosurgical, Active, Urological, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911…
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | 06/29/2026SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
Questions and answers
When was Reprocessed Endoscopic Electrodes cleared by the FDA?
Reprocessed Endoscopic Electrodes (K012685) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 184 days after the submission was received.
What is the product code of K012685?
The FDA product code is NLW – Electrode, Electrosurgical, Active, Urological, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.4300.