Kapp Bari-Ring, Model KS-BR-2005
FDA 510(k) K050384 · Kapp Surgical Instrument, Inc.
510(k) numberK050384
Submission
- Device name
- Kapp Bari-Ring, Model KS-BR-2005
- Applicant
- Kapp Surgical Instrument, Inc.
Warrensville, OH, US - Received
- February 15, 2005
- Decision date
- January 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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|---|---|---|
| K200289 | Michler-Kapp Cardiovascular Vent CatheterDWF · Traditional | 01/28/2021SE |
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536NEU · Special | 11/09/2007SE |
| K050657 | Mondeal Contour Ho SystemHRS · Traditional | 08/08/2005SE |
| K050655 | Mondeal Radius Ho System, Model KS-MR-2005HRS · Traditional | 08/08/2005SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | 07/28/2004SE |
| K030237 | Kapp Custom Radial Head Elbow ImplantKWI · Traditional | 08/29/2003SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | 11/08/1984SE |
| K843368 | Kapp Spinal ButtonHTN · Traditional | 09/12/1984SE |
Questions and answers
When was Kapp Bari-Ring, Model KS-BR-2005 cleared by the FDA?
Kapp Bari-Ring, Model KS-BR-2005 (K050384) received a 510(k) decision of Substantially Equivalent on January 13, 2006, 332 days after the submission was received.
What is the product code of K050384?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.