Suture Clip Remover
FDA 510(k) K771640 · United States Surgical, A Division of Tyco Healthc
510(k) numberK771640
Submission
- Device name
- Suture Clip Remover
- Applicant
- United States Surgical, A Division of Tyco Healthc
Mchenry, IL, US - Received
- August 29, 1977
- Decision date
- September 30, 1977
- 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 |
| K791157 | 360 Hemoclip AppliersGDO · Traditional | Edward Weck, Inc. | 06/27/1979SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071406 | Autosuture Endo Clip III 5 MM Clip ApplierFZP · Traditional | 11/21/2007SE |
| K071920 | Autosuture Absorbable Tack and ApplicatorGDW · Traditional | 09/28/2007SE |
| K061288 | Auto Suture Endo Clip III 5 MM Clip ApplierFZP · Special | 11/02/2006SE |
| K062850 | Autosuture Circular Eea Surgical StaplersGDW · Special | 10/23/2006SE |
| K062326 | Autosuture Modified Versaport Trocar with Fixation SleeveGCJ · Special | 09/01/2006SE |
| K061095 | Auto Sutur Endo Gia StaplersGDW · Traditional | 05/31/2006SE |
| K050947 | Modification to: Modified Uss Polypropylene SutureGAW · Special | 06/01/2005SE |
| K042412 | Modified Spacemaker SystemGCJ · Special | 09/24/2004SE |
| K040594 | Herculon Soft Tissue Reattachment SystemHWC · Special | 03/31/2004SE |
| K032696 | Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…GDW · Traditional | 12/01/2003SE |
Questions and answers
When was Suture Clip Remover cleared by the FDA?
Suture Clip Remover (K771640) received a 510(k) decision of Substantially Equivalent on September 30, 1977, 32 days after the submission was received.
What is the product code of K771640?
The FDA product code is GDO – Applier, Surgical, Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.