Auto Suture(R) Endoscopic Fan Retractor
FDA 510(k) K914190 · United States Surgical, A Division of Tyco Healthc
510(k) numberK914190
Submission
- Device name
- Auto Suture(R) Endoscopic Fan Retractor
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- September 18, 1991
- Decision date
- May 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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More from Hct, 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 Auto Suture(R) Endoscopic Fan Retractor cleared by the FDA?
Auto Suture(R) Endoscopic Fan Retractor (K914190) received a 510(k) decision of Substantially Equivalent on May 6, 1992, 231 days after the submission was received.
What is the product code of K914190?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.