Needleholder, Microvasular 5 1/2
FDA 510(k) K780154 · Edward Weck, Inc.
510(k) numberK780154
Submission
- Device name
- Needleholder, Microvasular 5 1/2
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- January 30, 1978
- Decision date
- March 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNM – Needle, Ophthalmic Suturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K844448 | Oms/Gonvers Retinal PerforatorHNM · Traditional | Optical Micro Systems, Inc. | 08/21/1985SE |
More from Optical Micro Systems, 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 Needleholder, Microvasular 5 1/2 cleared by the FDA?
Needleholder, Microvasular 5 1/2 (K780154) received a 510(k) decision of Substantially Equivalent on March 17, 1978, 46 days after the submission was received.
What is the product code of K780154?
The FDA product code is HNM – Needle, Ophthalmic Suturing, a Class I (low risk) device regulated under 21 CFR 886.4350.