FDA Product Code
FDA Product Code NEU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4300
510(k) Clearances — 110 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033447 | CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 | Mri Devices Corp. | 2004-01-28 | Traditional | PDF ↗ |
| K031938 | GEL MARK III BIOPSY SITE MARKER | Senorx, Inc. | 2003-09-05 | Traditional | PDF ↗ |
| K023694 | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2003-03-17 | Traditional | PDF ↗ |
| K023450 | BIOPSY SITE TISSUE MARKER DEVICE | Promex, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K020276 | 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 | Ethicon Endo-Surgery, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K014148 | SELF-DRILLING RADIOGRAPHIC MARKER | Walter Lorenz Surgical, Inc. | 2002-01-17 | Special | PDF ↗ |
| K013413 | MICROMARK II TISSUE MARKER,MODEL C1535 | Ethicon Endo-Surgery, Inc. | 2001-12-03 | Traditional | PDF ↗ |
| K012955 | COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER | Bioform, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K011856 | RADIOGRAPHIC MARKERS | Encore Orthopedics, Inc. | 2001-08-22 | Traditional | PDF ↗ |
| K010348 | TANTALUM BEADS - RADIOGRAPHIC MARKER | Biomet, Inc. | 2001-05-03 | Traditional | PDF ↗ |
Product code NEU · Class II · General, Plastic Surgery. Data: openFDA.