# K072216: Kapp Bari-Ring Endoscopic Marker, Model K-9536

- Pathway: 510(k) (Special)
- Applicant: Kapp Surgical Instrument, Inc.
- Decided: Nov 9, 2007 after 92 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970817 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050384: Kapp Bari-Ring, Model KS-BR-2005, Kapp Surgical Instrument, Inc. (2006) Summary page 1.
- K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376, Mri Devices Corp. (2004) Summary page 1.

## Recalls of this device
- May 24, 2011 · Not classified · Z-2753-2011: During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions containe

## Indications for use
The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

Source page: https://510kreport.com/device/K072216
Methodology: https://510kreport.com/methodology