360 Hemoclip Appliers
FDA 510(k) K791157 · Edward Weck, Inc.
510(k) numberK791157
Submission
- Device name
- 360 Hemoclip Appliers
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- June 21, 1979
- Decision date
- June 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDO – Applier, Surgical, Clip
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926199 | Uniclip Surgical Clip ApplierGDO · Traditional | Unisurge, Inc. | 04/20/1993SE |
| K890941 | Modified Suture Disp. Endoscopic Surgical Clip AppGDO · Traditional | United States Surgical, A Division of Tyco Healthc | 04/07/1989SE |
| K890159 | Towel ClipsGDO · Traditional | Dhason Brothers, Inc. | 02/03/1989SE |
| K890233 | Suture Clip Applier/RemoverGDO · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K820837 | Disposable Multiple Ligating ClipGDO · Traditional | ETHICON, Inc. | 05/28/1982SE |
| K812291 | Ethicon Multiple Ligating Clip ApplierGDO · Traditional | ETHICON, Inc. | 09/11/1981SE |
| K792378 | Hemospenser Cartridge Cat. No. 523500-GDO · Traditional | Edward Weck, Inc. | 12/06/1979SE |
| K791845 | Bayonet Heifetz Clip AppliersGDO · Traditional | Edward Weck, Inc. | 10/17/1979SE |
| K790855 | Surgical Drape Clip #201GDO · Traditional | C. Intl. | 08/03/1979SE |
| K790990 | Reynolds Double Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/05/1979SE |
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 360 Hemoclip Appliers cleared by the FDA?
360 Hemoclip Appliers (K791157) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 6 days after the submission was received.
What is the product code of K791157?
The FDA product code is GDO – Applier, Surgical, Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.