KCZ
13 FDA 510(k) clearances · Product code
56 daysmedian time to decision
188 days90th percentile
13clearances measured
FDA profile
- Official device name
- Prosthesis, Breast, External, Used With Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1993: 4 · 1998: 2 · 2000: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STRAUMANN EXTRAORAL IMPLANT SYSTEM (K990458) | Straumann USA | 1999-04-16 |
| MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324) | Maxol Limited L.C. | 1995-05-26 |
| COSMET (K933465) | Great Bay Medical Products, Inc. | 1994-07-20 |
| CALSSIQUE OR MYSTIQUE (K932978) | Dekumed, Kunststofftechnik Degler GmbH | 1993-12-22 |
| CLASSIQUE (K932899) | Hemispheres Marketing Co. , Ltd. | 1993-12-16 |
| ALMOST U, INC. BREAST PROSTHESIS (K933668) | Almost U., Inc. | 1993-12-10 |
| SUOENA AFFINITY (TM) MODEL #802 (K921535) | Coloplast Corp. | 1992-05-11 |
| AMOENA AFFINITY MODEL #802 (K915382) | Coloplast Corp. | 1992-01-14 |
| YOURS TRULY ASYMMETRICAL BREAST FORM (K911247) | Jobst Institute, Inc. | 1991-03-29 |
| ELLA BREAST FORM (K904085) | Coloplast A/S | 1990-10-31 |
| NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (K904316) | Coloplast Corp. | 1990-10-11 |
| DISCRENE SELF-SUPPORTING BREAST FORM (K904086) | Coloplast A/S | 1990-10-02 |
| SPENCO BREAST FORMS (K896533) | Spenco Medical Corp. | 1989-12-13 |
Track KCZ automatically
Every clearance here is in the API, with alerts when new ones post.