Suture Tissue Approximating Forcep
FDA 510(k) K771515 · United States Surgical, A Division of Tyco Healthc
510(k) numberK771515
Submission
- Device name
- Suture Tissue Approximating Forcep
- Applicant
- United States Surgical, A Division of Tyco Healthc
Mchenry, IL, US - Received
- August 8, 1977
- Decision date
- September 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEN – Forceps, 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 GEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900951 | GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
More from Zinnanti Surgical Instruments, 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 Tissue Approximating Forcep cleared by the FDA?
Suture Tissue Approximating Forcep (K771515) received a 510(k) decision of Substantially Equivalent on September 30, 1977, 53 days after the submission was received.
What is the product code of K771515?
The FDA product code is GEN – Forceps, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.