Allport Mastoid Retractors
FDA 510(k) K772392 · Edward Weck, Inc.
510(k) numberK772392
Submission
- Device name
- Allport Mastoid Retractors
- 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
- KAL – Retractor, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870758 | Small Mastoid RetractorKAL · Traditional | Treace Medical, Inc. | 03/04/1987SE |
| K833604 | Adjustable Fork RetractorKAL · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K772381 | Ring Handle & RetractorsKAL · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K760851 | Converse Altar RetractorKAL · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 03/10/1977SE |
More from V. Mueller O.V. Baxter Healthcare Corp.
| 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 Allport Mastoid Retractors cleared by the FDA?
Allport Mastoid Retractors (K772392) 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 K772392?
The FDA product code is KAL – Retractor, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.