Panda(R) Needle Catheter Jejunostomy Tube
FDA 510(k) K891109 · Concept, Inc.
510(k) numberK891109
Submission
- Device name
- Panda(R) Needle Catheter Jejunostomy Tube
- Applicant
- Concept, Inc.
Largo, FL, US - Received
- March 2, 1989
- Decision date
- May 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
| K874676 | Interference ScrewHWC · Traditional | 03/07/1988SE |
Questions and answers
When was Panda(R) Needle Catheter Jejunostomy Tube cleared by the FDA?
Panda(R) Needle Catheter Jejunostomy Tube (K891109) received a 510(k) decision of Substantially Equivalent on May 8, 1989, 67 days after the submission was received.
What is the product code of K891109?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.