Mountable Endoscopic Knife
FDA 510(k) K982142 · A.M. Surgical, Inc.
510(k) numberK982142
Submission
- Device name
- Mountable Endoscopic Knife
- Applicant
- A.M. Surgical, Inc.
Smithtown, NY, US - Received
- June 17, 1998
- Decision date
- December 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | Surgipath Medical Industries, Inc. | 09/30/1986SE |
| 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 |
|---|---|---|
| K191771 | SECURE ScrewHWC · Traditional | 10/16/2019SE |
| K191345 | Pegasus SystemHRX · Traditional | 07/17/2019SE |
| K180087 | A.M. Surgical Intramedullary Fixation DeviceHTY · Traditional | 05/18/2018SE |
| K080133 | Mountable Endoscopic BladeEMF · Traditional | 03/13/2008SE |
| K042458 | A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemLXT · Traditional | 10/07/2004SE |
Questions and answers
When was Mountable Endoscopic Knife cleared by the FDA?
Mountable Endoscopic Knife (K982142) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 196 days after the submission was received.
What is the product code of K982142?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.