Conphar Nelaton Catheter-Sterile
FDA 510(k) K791264 · Conphar, Inc.
510(k) numberK791264
Submission
- Device name
- Conphar Nelaton Catheter-Sterile
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- July 6, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Nelaton Catheter-Sterile cleared by the FDA?
Conphar Nelaton Catheter-Sterile (K791264) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 28 days after the submission was received.
What is the product code of K791264?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.