Auto Suture Pituitary Spinal Rongeur
FDA 510(k) K943115 · United States Surgical, A Division of Tyco Healthc
510(k) numberK943115
Submission
- Device name
- Auto Suture Pituitary Spinal Rongeur
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- June 27, 1994
- Decision date
- July 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K942971 | Auto Suture Spinal DissectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942970 | Auto Suture Spinal ElevatorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942969 | Auto Suture Spinal Nerve HookHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942968 | Auto Suture Spinal OsteotomeHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942967 | Auto Suture Spinal CuretteHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
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More from Acra Cut, 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 Pituitary Spinal Rongeur cleared by the FDA?
Auto Suture Pituitary Spinal Rongeur (K943115) received a 510(k) decision of Substantially Equivalent on July 25, 1994, 28 days after the submission was received.
What is the product code of K943115?
The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.