Dingman Zygoma Elevator
FDA 510(k) K772399 · Edward Weck, Inc.
510(k) numberK772399
Submission
- Device name
- Dingman Zygoma Elevator
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- January 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAD – Elevator, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841356 | ElevatorKAD · Traditional | Treace Medical, Inc. | 07/18/1984SE |
| K822270 | Various Types of ENT ElevatorsKAD · Traditional | Kelleher Corp. | 08/16/1982SE |
| K822190 | ENT ElevatorsKAD · Traditional | Kelleher Corp. | 08/16/1982SE |
| K772391 | Boies Nasal Fracture ElevatorKAD · Traditional | Edward Weck, Inc. | 01/17/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
| K914690 | LM15(TM), Catalog Number - 523821GCJ · Traditional | 03/23/1992SE |
| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Dingman Zygoma Elevator cleared by the FDA?
Dingman Zygoma Elevator (K772399) received a 510(k) decision of Substantially Equivalent on January 17, 1978, 21 days after the submission was received.
What is the product code of K772399?
The FDA product code is KAD – Elevator, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.