Inject-Snare
FDA 510(k) K942110 · Endovations
510(k) numberK942110
Submission
- Device name
- Inject-Snare
- Applicant
- Endovations
Reading, PA, US - Received
- May 2, 1994
- Decision date
- October 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 02/21/2026SE |
| K221713 | Polypectomy SnareFDI · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/03/2023SE |
| K220846 | Core-SnareFDI · Traditional | Incore Co., Ltd. | 11/21/2022SE |
| K220089 | Disposable Polyp SnareFDI · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/22/2022SE |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDI · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/27/2022SE |
| K213222 | Disposable Polypectomy SnareFDI · Traditional | Beijing Zksk Technology Co., Ltd. | 06/06/2022SE |
| K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…FDI · Special | STERIS Corporation | 10/07/2021SE |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresFDI · Special | Boston Scientific Corporation | 10/08/2020SE |
| K200745 | Lariat, Hot/Cold SnareFDI · Special | United States Endoscopy Group, Inc. | 04/21/2020SE |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareFDI · Traditional | Intelligent Endoscopy | 11/22/2019SE |
More from Intelligent Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K955413 | Endovations Triple Lumen Balloon Dilatation CatheterFGE · Traditional | 02/08/1996SE |
| K944049 | Oxygen MouthguardMNK · Traditional | 10/11/1994SE |
| K934315 | Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional | 02/28/1994SE |
| K913841 | 2 Lumen Endos Retro Cholangiopancrea Injec CathFGE · Traditional | 10/08/1991SE |
| K913870 | 5MM MicroscissorsGCJ · Traditional | 09/16/1991SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | 08/07/1991SE |
| K892218 | Endo-SpongeMNL · Traditional | 05/31/1989SE |
| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | 12/08/1988SE |
| K873360 | Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional | 03/30/1988SE |
| K875264 | Washing CatheterOCX · Traditional | 03/29/1988SE |
Questions and answers
When was Inject-Snare cleared by the FDA?
Inject-Snare (K942110) received a 510(k) decision of Substantially Equivalent on October 13, 1994, 164 days after the submission was received.
What is the product code of K942110?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.