Auto Suture Disposable Endoscopic Specimen Pouch
FDA 510(k) K922123 · United States Surgical, A Division of Tyco Healthc
510(k) numberK922123
Submission
- Device name
- Auto Suture Disposable Endoscopic Specimen Pouch
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- May 6, 1992
- Decision date
- February 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCI – Laryngoscope, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K915762 | Poole Tip Suction ProbeGCI · Traditional | O.R. Concepts, Inc. | 03/13/1992SE |
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More from ETHICON, 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 Disposable Endoscopic Specimen Pouch cleared by the FDA?
Auto Suture Disposable Endoscopic Specimen Pouch (K922123) received a 510(k) decision of Substantially Equivalent on February 1, 1993, 271 days after the submission was received.
What is the product code of K922123?
The FDA product code is GCI – Laryngoscope, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.