Subpart E—Surgical Devices
FDA submissions for Subpart E—Surgical Devices in the Gastroenterology, Urology (GU) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 876.4020–876.4890
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 876.4020 | 2 | 10 |
| QEJ | Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries | 876.4100 | 2 | 2 |
| EZP | Rod, Colostomy | 876.4270 | 2 | 2 |
| FAR | Unit, Electrosurgical | 876.4300 | 2 | 0 |
| FAS | Electrode, Electrosurgical, Active, Urological | 876.4300 | 2 | 58 |
| FBJ | Cord, Electric For Transurethral Surgical Instrument | 876.4300 | 2 | 0 |
| FDB | Plate, Patient | 876.4300 | 2 | 0 |
| FDI | Snare, Flexible | 876.4300 | 2 | 63 |
| FDJ | Snare, Rigid Self-Opening | 876.4300 | 2 | 0 |
| FDL | Wristlet, Patient Return | 876.4300 | 2 | 0 |
| FEH | Electrode, Flexible Suction Coagulator | 876.4300 | 2 | 3 |
| FFI | System, Alarm, Electrosurgical | 876.4300 | 2 | 1 |
| FGW | Clamp, Electrical | 876.4300 | 2 | 0 |
| FHC | Adaptor To The Cord, For Transurethral Surgical Instrument | 876.4300 | 2 | 0 |
| FHY | Jelly, Contact, For Transurethral Surgical Instrument | 876.4300 | 2 | 0 |
| FHZ | Desiccator, Transurethral | 876.4300 | 2 | 0 |
| KGE | Forceps, Biopsy, Electric | 876.4300 | 2 | 46 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 876.4300 | 2 | 187 |
| NLR | Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed | 876.4300 | 2 | 1 |
| NLT | Snare, Flexible, Reprocessed | 876.4300 | 2 | 0 |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 876.4300 | 2 | 4 |
| NLV | Electrode, Flexible Suction Coagulator, Reprocessed | 876.4300 | 2 | 0 |
| NLW | Electrode, Electrosurgical, Active, Urological, Reprocessed | 876.4300 | 2 | 1 |
| NWI | Electrosurgical Electrode Kit | 876.4300 | 2 | 0 |
| OEJ | Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia | 876.4300 | 2 | 0 |
| OEK | Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia | 876.4300 | 2 | 0 |
| QEC | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree | 876.4300 | 2 | 1 |
| QNE | Endoscopic Pancreatic Debridement Device | 876.4330 | 2 | 1 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 876.4340 | 2 | 13 |
| FFD | Evacuator, Bladder, Manually Operated | 876.4370 | 1 | 2 |
| FHF | System, Evacuator, Fluid | 876.4370 | 2 | 3 |
| KQT | Evacuator, Gastro-Urology | 876.4370 | 2 | 14 |
| PRU | Gastric Lavage Kit (Adult Or Pediatric Use) | 876.4370 | 2 | 0 |
| FHN | Ligator, Hemorrhoidal | 876.4400 | 2 | 22 |
| MND | Ligator, Esophageal | 876.4400 | 2 | 15 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 876.4400 | 2 | 62 |
| QSW | Endoscopic Traction Device | 876.4410 | 2 | 2 |
| FEO | Lithotriptor, Ultrasonic | 876.4480 | 2 | 14 |
| FFK | Lithotriptor, Electro-Hydraulic | 876.4480 | 2 | 61 |
| FGK | Tripsor, Stone, Bladder | 876.4500 | 2 | 1 |
| LQC | Lithotriptor, Biliary Mechanical | 876.4500 | 2 | 11 |
| FDG | Retractor, Fiberoptic | 876.4530 | 1 | 2 |
| EYS | Ribdam | 876.4560 | 1 | 0 |
| FBS | Sound, Metal, Interconnected | 876.4590 | 1 | 1 |
| FAD | Stent, Ureteral | 876.4620 | 2 | 122 |
| QGB | Ureteral Stent Accessories | 876.4630 | 1 | 0 |
| FFE | System, Water Jet Catheter, Renal | 876.4650 | 2 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 876.4680 | 2 | 52 |
| FGO | Dislodger, Stone, Flexible | 876.4680 | 2 | 19 |
| NQT | Dislodger, Stone, Flexible, Ureteral, Reprocessed | 876.4680 | 2 | 0 |
| NQU | Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed | 876.4680 | 2 | 0 |
| NQV | Catheter, Suction, Tracheobronchial, Reprocessed | 876.4680 | 1 | 0 |
| ONJ | Dissolvable Gel For Preventing Ureteral Stone Migration | 876.4680 | 2 | 1 |
| QNA | Ultrasonic Urinary Stone Propulsion Device | 876.4690 | 2 | 1 |
| EXX | Probe, Rectal, Non-Powered | 876.4730 | 1 | 0 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 876.4730 | 1 | 2 |
| FFN | Clamp, Non-Electrical | 876.4730 | 1 | 5 |
| FFO | Retractor, Self-Retaining | 876.4730 | 1 | 5 |
| FFQ | Speculum, Rectal | 876.4730 | 1 | 1 |
| FFR | Device, Locking, For Intestinal Clamp | 876.4730 | 1 | 0 |
| FGM | Probe And Director, Gastro-Urology | 876.4730 | 1 | 7 |
| FGN | Retractor, Non-Self-Retaining | 876.4730 | 1 | 0 |
| FGX | Snare, Non-Electrical | 876.4730 | 1 | 0 |
| FHB | Hook, Gastro-Urology | 876.4730 | 1 | 0 |
| FHH | Crusher, Spur, Colostomy | 876.4730 | 1 | 0 |
| FHI | Ring, Laparotomy | 876.4730 | 1 | 0 |
| FHK | Spreader, Bladder Neck | 876.4730 | 1 | 0 |
| FHL | Scoop | 876.4730 | 1 | 0 |
| FHQ | Holder, Needle, Gastroenterologic | 876.4730 | 1 | 7 |
| FKK | Clamp, Line | 876.4730 | 1 | 6 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 876.4730 | 1 | 44 |
| OLH | Orchidometer | 876.4730 | 1 | 0 |
| OOW | Applicator For Rectal Suppository | 876.4730 | 1 | 1 |
| PVY | Vasovasostomy Set | 876.4730 | 1 | 0 |
| EZO | Urethrotome | 876.4770 | 2 | 5 |
| EYD | Stirrups | 876.4890 | 1 | 0 |
| EYH | Table, Cysto, Non-Electrical | 876.4890 | 1 | 0 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 876.4890 | 1 | 8 |
| MMZ | Table, Cystometric, Electric | 876.4890 | 2 | 4 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Apr 8, 2026 |
| K253734 | Taurus Clip | Taurus Endoscopy | Mar 12, 2026 |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | Mar 6, 2026 |
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | Feb 21, 2026 |
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Feb 20, 2026 |
| K251469 | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | Dec 19, 2025 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | Dec 18, 2025 |
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | Dec 5, 2025 |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | Nov 26, 2025 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | Nov 25, 2025 |
| K251910 | Focal One® | Edap Technomed, Inc. | Nov 19, 2025 |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Nov 12, 2025 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | Oct 17, 2025 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | Oct 10, 2025 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | Oct 7, 2025 |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | Sep 29, 2025 |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | Sep 8, 2025 |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Aug 8, 2025 |
| K250522 | Multi4 System | Multi4 Medical AB | Jun 27, 2025 |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Jun 18, 2025 |
| K250584 | Rezum System | Boston Scientific Corporation | Jun 11, 2025 |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | Jun 6, 2025 |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | May 21, 2025 |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | May 14, 2025 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Apr 18, 2025 |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation | Apr 15, 2025 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | Mar 26, 2025 |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | Feb 6, 2025 |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | Feb 6, 2025 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | Jan 17, 2025 |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | Jan 2, 2025 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Dec 12, 2024 |
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | Oct 30, 2024 |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Sep 17, 2024 |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | Aug 26, 2024 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | Aug 15, 2024 |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | Jul 12, 2024 |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | Jun 12, 2024 |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | Jun 7, 2024 |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | Jun 3, 2024 |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | May 9, 2024 |
| K240925 | DuraGraft Vascular Conduit Solution | Marizyme | May 1, 2024 |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 29, 2024 |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | Mar 22, 2024 |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | Mar 19, 2024 |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | Jan 26, 2024 |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Jan 11, 2024 |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | Dec 14, 2023 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | Nov 28, 2023 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | Nov 7, 2023 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | Oct 31, 2023 |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. | Oct 30, 2023 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation | Oct 27, 2023 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | Oct 25, 2023 |
| K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | Oct 23, 2023 |
| DEN230002 | DuraGraft | Marizyme, Inc. | Oct 4, 2023 |
| K230692 | TULSA-PRO System | Profound Medical, Inc. | Sep 20, 2023 |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | Aug 31, 2023 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | Aug 14, 2023 |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jul 31, 2023 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | Jun 21, 2023 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | May 3, 2023 |
| K223256 | Optimos Cystotome | Taewoong Medical Co., Ltd. | Apr 5, 2023 |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 28, 2023 |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | Mar 3, 2023 |
| K220846 | CORE-SNARE | Incore Co., Ltd. | Nov 21, 2022 |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | Nov 14, 2022 |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg | Boston Scientific Corporation | Nov 10, 2022 |
| K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | Oct 3, 2022 |
| K220089 | Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Sep 22, 2022 |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | Sep 21, 2022 |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | Sep 14, 2022 |
| K211858 | TULSA-PRO System | Profound Medical, Inc. | Sep 6, 2022 |
| K221124 | MANTIS Clip | Boston Scientific Corporation | Aug 4, 2022 |
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Jul 12, 2022 |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jun 27, 2022 |
| K213338 | CORE-CLIP | Incore Co., Ltd. | Jun 23, 2022 |
| K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | Jun 13, 2022 |
| DEN220006 | ProdiGI | Covidien, LLC | Jun 13, 2022 |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | Jun 9, 2022 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Coloplast Corp. | Jun 8, 2022 |
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | Jun 6, 2022 |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | Jun 6, 2022 |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | May 27, 2022 |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | Mar 21, 2022 |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | Mar 17, 2022 |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Mar 3, 2022 |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | Mar 2, 2022 |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | Feb 16, 2022 |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | Feb 4, 2022 |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | Jan 26, 2022 |
| K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | Jan 20, 2022 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | Dec 17, 2021 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | Dec 1, 2021 |
| K212150 | Exablate Prostate System | Insightec, Inc. | Nov 23, 2021 |
| K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) | STERIS Corporation | Oct 7, 2021 |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | Oct 5, 2021 |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | Aug 25, 2021 |
