Disposable Base Mold
FDA 510(k) K831335 · Surgipath Medical Industries, Inc.
510(k) numberK831335
Submission
- Device name
- Disposable Base Mold
- Applicant
- Surgipath Medical Industries, Inc.
Mchenry, IL, US - Received
- April 25, 1983
- Decision date
- May 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831922 | Embedding RingKER · Traditional | Polymer Technology Corp. | 07/29/1983SE |
| K831900 | Maclean-Fogg, Disp. Base MoldKER · Traditional | Polymer Technology Corp. | 07/28/1983SE |
| K831333 | Embedding RingsKER · Traditional | Surgipath Medical Industries, Inc. | 05/25/1983SE |
| K772149 | Lancer Biopsy HolderKER · Traditional | Sherwood Medical Industries | 11/22/1977SE |
More from Sherwood Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K883217 | Schiff ReagentHZT · Traditional | 08/05/1988SE |
| K881921 | C-E BrushHHT · Traditional | 07/19/1988SE |
| K881922 | Cytojars Prefilled with Cytology PreservativeLDZ · Traditional | 05/25/1988SE |
| K881659 | Tissue Section AdhesiveIFZ · Traditional | 04/21/1988SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | 09/30/1986SE |
| K863616 | Knife MakerIDL · Traditional | 09/25/1986SE |
| K863548 | Rotary MicrotomeIDO · Traditional | 09/19/1986SE |
| K863483 | Cassette EmbosseerIDZ · Traditional | 09/16/1986SE |
| K863145 | Cervical ScrapersHHT · Traditional | 08/19/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | 04/11/1986SE |
Questions and answers
When was Disposable Base Mold cleared by the FDA?
Disposable Base Mold (K831335) received a 510(k) decision of Substantially Equivalent on May 16, 1983, 21 days after the submission was received.
What is the product code of K831335?
The FDA product code is KER – Container, Embedding, a Class I (low risk) device regulated under 21 CFR 864.3010.