Reusable/Disposable Autopsy Knife Set
FDA 510(k) K863549 · Surgipath Medical Industries, Inc.
510(k) numberK863549
Submission
- Device name
- Reusable/Disposable Autopsy Knife Set
- Applicant
- Surgipath Medical Industries, Inc.
Grayslake, IL, US - Received
- September 12, 1986
- Decision date
- September 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EMF – Knife, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080133 | Mountable Endoscopic BladeEMF · Traditional | A.M. Surgical, Inc. | 03/13/2008SE |
| K982142 | Mountable Endoscopic KnifeEMF · Traditional | A.M. Surgical, Inc. | 12/30/1998SE |
| K890217 | Microsurgical KnivesEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890215 | Microsurgical ScarifierEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890214 | Microsurgery Razor Blade HolderEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | Van-Tec, Inc. | 02/29/1988SE |
| K863752 | Valtrac (Bar) Remover DeviceEMF · Traditional | Davis & Geck, Inc. | 10/24/1986SE |
| K861947 | Surgical KnifeEMF · Traditional | Sharpoint, Inc. | 06/06/1986SE |
| K854891 | KnifeEMF · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K851784 | 27-210 Plaster Knife (Reiner)EMF · Traditional | Artiberia | 06/20/1985SE |
More from Artiberia
| 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 |
| 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 |
| K861201 | Formaldehyde Solution, 37%IGG · Traditional | 04/11/1986SE |
Questions and answers
When was Reusable/Disposable Autopsy Knife Set cleared by the FDA?
Reusable/Disposable Autopsy Knife Set (K863549) received a 510(k) decision of Substantially Equivalent on September 30, 1986, 18 days after the submission was received.
What is the product code of K863549?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.