27-210 Plaster Knife (Reiner)
FDA 510(k) K851784 · Artiberia
510(k) numberK851784
Submission
- Device name
- 27-210 Plaster Knife (Reiner)
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- June 20, 1985
- 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 |
| 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 |
More from Euro-Med Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
Questions and answers
When was 27-210 Plaster Knife (Reiner) cleared by the FDA?
27-210 Plaster Knife (Reiner) (K851784) received a 510(k) decision of Substantially Equivalent on June 20, 1985, 56 days after the submission was received.
What is the product code of K851784?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.