Product code KER
- Device name
- Container, Embedding
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831922 | EMBEDDING RING | Polymer Technology Corp. | 1983-07-29 |
| K831900 | MACLEAN-FOGG, DISP. BASE MOLD | Polymer Technology Corp. | 1983-07-28 |
| K831333 | EMBEDDING RINGS | Surgipath Medical Industries, Inc. | 1983-05-25 |
| K831335 | DISPOSABLE BASE MOLD | Surgipath Medical Industries, Inc. | 1983-05-16 |
| K772149 | LANCER BIOPSY HOLDER | Sherwood Medical Industries | 1977-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971182571166 | Embedding Cassette | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2024-12-27 |
| 06971182571173 | Embedding Cassette | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2024-12-27 |
| 06971182571180 | Embedding Cassette | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2024-12-27 |
| 06971182571197 | Embedding Cassette | Dakewe (Shenzhen) Medical Equipment Co., Ltd. | 2024-12-27 |
| 00673693227506 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-08 |
| 00673693227513 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-08 |
| 00673693227520 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-08 |
| 00673693227537 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-10-08 |
| 00673693224147 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693224130 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693220460 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693219327 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693219310 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693218368 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693214254 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693224154 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-02 |
| 00673693224116 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 00673693083768 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 00673693083775 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 00673693083782 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 00673693083751 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 00673693224123 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-01 |
| 10615233078770 | Cryomold® | SAKURA FINETEK U.S.A., INC. | 2020-03-17 |
| 10615233078787 | Cryomold® | SAKURA FINETEK U.S.A., INC. | 2020-03-17 |
| 00615233013743 | Tissue-Tek® | SAKURA FINETEK U.S.A., INC. | 2019-12-25 |
| 00615233013750 | Tissue-Tek® | SAKURA FINETEK U.S.A., INC. | 2019-12-25 |
| 00615233013767 | Tissue-Tek® | SAKURA FINETEK U.S.A., INC. | 2019-12-25 |
| 10615233078640 | Tissue-Tek® Cryomold® | SAKURA FINETEK U.S.A., INC. | 2019-12-23 |
| 10615233078633 | Tissue-Tek® Cryomold® | SAKURA FINETEK U.S.A., INC. | 2019-12-23 |
| 10615233078626 | Tissue-Tek® Cryomold® | SAKURA FINETEK U.S.A., INC. | 2019-12-23 |