FDA product code KCZ: Prosthesis, Breast, External, Used With Adhesive
KCZ is the FDA product code for prosthesis, breast, external, used with adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under KCZ, from 10 different applicants. The average 510(k) review took 95 days (median 56). FDA has posted 1 recall for KCZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class I |
| Regulation | 21 CFR 878.3800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KCZ clearance
Top KCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast Corp. | 3 | 1992-05-11 |
| Coloplast A/S | 2 | 1990-10-31 |
| Straumann USA | 1 | 1999-04-16 |
| Maxol Limited L.C. | 1 | 1995-05-26 |
| Great Bay Medical Products, Inc. | 1 | 1994-07-20 |
5 more applicants have KCZ clearances. See the full list in Caduvo.
Most recent KCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990458 | Straumann USA | STRAUMANN EXTRAORAL IMPLANT SYSTEM | 1999-04-16 | 63 |
| K951324 | Maxol Limited L.C. | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | 1995-05-26 | 64 |
| K933465 | Great Bay Medical Products, Inc. | COSMET | 1994-07-20 | 369 |
| K932978 | Dekumed, Kunststofftechnik Degler GmbH | CALSSIQUE OR MYSTIQUE | 1993-12-22 | 188 |
| K932899 | Hemispheres Marketing Co. , Ltd. | CLASSIQUE | 1993-12-16 | 185 |
Recalls for KCZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-11.
| Year | Recalls |
|---|---|
| 2019 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code KCZ?
KCZ is the FDA product code for prosthesis, breast, external, used with adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel.
What device class is KCZ?
Class I, regulation 21 CFR 878.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCZ?
Across 13 cleared submissions the average was 95 days from receipt to decision (median 56).
Which companies have the most KCZ clearances?
Coloplast Corp. (3); Coloplast A/S (2); Straumann USA (1); Maxol Limited L.C. (1); Great Bay Medical Products, Inc. (1).
Have KCZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KCZ
- Run a recall and safety report across every KCZ manufacturer
- Watch product code KCZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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