Panels › Gastroenterology, Urology › Product code KNS · Class 2
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation 876.4300
4510(k)s in 12 months (189 all time)
43recalls in 12 months (125 all time)
122recalls that name a 510(k)
Top companies in KNS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. Open, Classified |
KNS | K123319 |
| Feb 13, 2026 | Wilson-Cook Medical Inc. Teslatome Bipolar Sphincterotomes
REF: TESLA-B2535-260
Model Number: G60784
UDI-DI code: 00827002607842
REF: TESLA-B2535-450
Model Number: G60785
UDI-DI code: 00827002607859
These devices are used f Open, Classified |
KNS | K243568 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0725;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K141991 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3025
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3020
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0725
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Brand Name: Disposable Triple Lumen Sphincterotome
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0320
Product Description: These instruments have been designed to Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-3030
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-1530
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-1520
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0730
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0330
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K950166 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0730
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number:KD-VC433Q-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used w Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC433Q-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC412Q-0215;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K160241 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0330;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0320;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K141991 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K141991 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC431Q-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0725;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0330;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-431Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC431Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and g Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Olympus Corporation of the Americas Brand Name: CleverCut
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0320;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | K250945 |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;
Material Number (UPN): M00553560; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;
Material Number (UPN): M00553530; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;
Material Number (UPN): M00553520; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;
Material Number (UPN): M00553690; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;
Material Number (UPN): M00553680; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;
Material Number (UPN): M00553660; Open, Classified |
KNS | K233318 |
| Jan 30, 2026 | Olympus Corporation of the Americas Brand Name: Single Use Electrosurgical Knife KD-645
Product Name: Olympus Single Use Electrosurgical Knife KD-645
Model/Catalog Number: KD-645L
Product Description: An electrosurgical device consistin Open, Classified |
KNS | K182408 |
| Jan 30, 2026 | Olympus Corporation of the Americas Brand Name: Single Use Electrosurgical Knife
Product Name: Olympus Single Use Electrosurgical Knife KD-640L
Model/Catalog Number: KD640-L
Product Description: An electrosurgical device consisting of a Open, Classified |
KNS | K092309 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553570 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553560 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553550 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553540 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553530 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553520 Open, Classified |
KNS | K233318 |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Delivery System 15mmx10mm
UPN: M00553750 Open, Classified |
KNS | K181905 |
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