Uniclip Surgical Clip Applier
FDA 510(k) K926199 · Unisurge, Inc.
510(k) numberK926199
Submission
- Device name
- Uniclip Surgical Clip Applier
- Applicant
- Unisurge, Inc.
Cupertino, CA, US - Received
- December 9, 1992
- Decision date
- April 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K791157 | 360 Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/27/1979SE |
| K790990 | Reynolds Double Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/05/1979SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943502 | UnigripGCJ · Traditional | 10/07/1994SE |
| K933720 | Instrument Actuating Device (Iad)GCJ · Traditional | 11/12/1993SE |
| K930605 | Applier, Surgical, ClipGCJ · Traditional | 10/08/1993SE |
| K930617 | Obgrip and Unitips(Tm)GCJ · Traditional | 08/11/1993SE |
| K932604 | Unigrip-Fh Surgical Handpiece/LaparoscopicGCJ · Traditional | 08/10/1993SE |
| K930809 | UnitipsGCJ · Traditional | 08/10/1993SE |
| K925917 | Unichannel(Tm Surgical GrasperGCJ · Traditional | 08/10/1993SE |
| K925882 | Unitips Surgical InstrumentsGCJ · Traditional | 08/10/1993SE |
| K926341 | Unitrocar(Tm) Reusable Surg Trocar/Resuse KitGCJ · Traditional | 05/17/1993SE |
| K914923 | Unisurge Disposable TrocarHET · Traditional | 09/21/1992SE |
Questions and answers
When was Uniclip Surgical Clip Applier cleared by the FDA?
Uniclip Surgical Clip Applier (K926199) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 132 days after the submission was received.
What is the product code of K926199?
The FDA product code is GDO – Applier, Surgical, Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.