Myringotomy Knife
FDA 510(k) K772384 · Edward Weck, Inc.
510(k) numberK772384
Submission
- Device name
- Myringotomy Knife
- 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
- JYO – Knife, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910212 | Color Doppler Option to Ai 5200 Diag Ultraso SystJYO · Traditional | Acoustic Imaging Technologies Corp. | 07/11/1991SE |
| K841006 | Ear Knife-VariousJYO · Traditional | Premier Dental Products Co. | 05/30/1984SE |
| K840764 | Ear KnivesJYO · Traditional | Sharpoint, Inc. | 05/21/1984SE |
| K833602 | Roller Knife-Transverse -SagittalJYO · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823911 | Knife Blade TipJYO · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K772372 | Roller KnifeJYO · 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 Myringotomy Knife cleared by the FDA?
Myringotomy Knife (K772384) 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 K772384?
The FDA product code is JYO – Knife, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.