Nerve Approximater
FDA 510(k) K780289 · Edward Weck, Inc.
510(k) numberK780289
Submission
- Device name
- Nerve Approximater
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- February 21, 1978
- Decision date
- June 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDG – Hook, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900069 | Modified PGL Absorbable Staple*GDG · Traditional | United States Surgical, A Division of Tyco Healthc | 04/16/1990SE |
| K891898 | Skin Hooks, Various TypesGDG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | Cedar Surgical, Inc. | 12/12/1986SE |
| K843136 | Brimfield Cannulated Grasping HooksGDG · Traditional | Brimfield Scientific Instruments | 09/25/1984SE |
| K841010 | Surgical Hooks, VariousGDG · Traditional | Premier Dental Products Co. | 05/01/1984SE |
| K812562 | Surgical Retractor & Elastic Stays, DispGDG · Traditional | Humboldt Products | 10/02/1981SE |
| K791120 | Middle Ear Picks, Hooks Curettes,GDG · Traditional | Xomed, Inc. | 07/10/1979SE |
| K771190 | Abramson Trachea Hook & RetractorGDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K771187 | Dermahook #382-805GDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
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 Nerve Approximater cleared by the FDA?
Nerve Approximater (K780289) received a 510(k) decision of Substantially Equivalent on June 14, 1978, 113 days after the submission was received.
What is the product code of K780289?
The FDA product code is GDG – Hook, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.