Laser Ureteral Catheter
FDA 510(k) K181431 · Cook Incorporated
510(k) numberK181431
Submission
- Device name
- Laser Ureteral Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- June 1, 2018
- Decision date
- July 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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Questions and answers
When was Laser Ureteral Catheter cleared by the FDA?
Laser Ureteral Catheter (K181431) received a 510(k) decision of Substantially Equivalent on July 30, 2018, 59 days after the submission was received.
What is the product code of K181431?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.