Inscope Multi-Clip Applier, Models IN22321, IN23321
FDA 510(k) K051950 · Ethicon Endo-Surgery, Inc.
510(k) numberK051950
Submission
- Device name
- Inscope Multi-Clip Applier, Models IN22321, IN23321
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- July 18, 2005
- Decision date
- October 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MND – Ligator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MND
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|---|---|---|---|
| K132535 | Autoband LigatorMND · Special | Endochoice, Inc. | 08/23/2013SE |
| K083556 | Modification to Auto-Band LigatorMND · Special | Scandimed International | 02/19/2009SE |
| K081142 | Auto-Band LigatorMND · Special | Scandimed International | 05/16/2008SE |
| K031236 | Auto-Band LigatorMND · Traditional | Scandimed. A.S. | 11/14/2003SE |
| K033245 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Special | C.R. Bard, Inc. | 11/06/2003SE |
| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Traditional | C.R. Bard, Inc. | 08/05/2002SE |
| K013066 | HX-5/6-1 Endoscopic Clipping DeviceMND · Traditional | Olympus America, Inc. | 12/11/2001SE |
| K001744 | Olympus Endoscopic Ligation DeviceMND · Traditional | Olympus America, Inc. | 02/27/2001SE |
| K990864 | Speedband Superview Multiple Band Ligator, Models 4225, 4228MND · Traditional | Boston Scientific Corp | 06/11/1999SE |
| K984255 | Olympus HX-20 Series Ligating DeviceMND · Traditional | Olympus Corp of America | 01/12/1999SE |
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| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | 10/28/2024SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | 07/03/2024SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | 08/29/2023SE |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…GEI · Traditional | 04/13/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | 03/15/2023SE |
Questions and answers
When was Inscope Multi-Clip Applier, Models IN22321, IN23321 cleared by the FDA?
Inscope Multi-Clip Applier, Models IN22321, IN23321 (K051950) received a 510(k) decision of Substantially Equivalent on October 7, 2005, 81 days after the submission was received.
What is the product code of K051950?
The FDA product code is MND – Ligator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.