Container, Embedding
Embedding Container is a device used in histological tissue processing to hold and mold the paraffin wax block around tissue specimens, creating a standardized block that can be mounted on a microtome for thin sectioning. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KER, regulated under 21 CFR 864.3010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- KER
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831922 | EMBEDDING RING | Jul 29, 1983 | Substantially Equivalent | Polymer Technology Corp. |
| K831900 | MACLEAN-FOGG, DISP. BASE MOLD | Jul 28, 1983 | Substantially Equivalent | Polymer Technology Corp. |
| K831333 | EMBEDDING RINGS | May 25, 1983 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K831335 | DISPOSABLE BASE MOLD | May 16, 1983 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K772149 | LANCER BIOPSY HOLDER | Nov 22, 1977 | Substantially Equivalent | Sherwood Medical Industries |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.