| 节号 |
中译文 |
原英文 |
| A亚部――总则（General Provisions） |
| 876.1 |
范围 |
Scope |
| 876.3 |
有关上市前批准生效日期的要求 |
Effective dates of requirement for premarket approval |
| 876.9 |
联邦食品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act，FDCA）第510（k）节的豁免限制 |
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act） |
| B亚部――诊断器械（Diagnostic Devices） |
| 876.1075 |
肠胃病学－泌尿学活组织检查器具 |
Gastroenterology-urology biopsy instrument |
| 876.1300 |
遥感勘测胃肠可吸收胶囊的成像系统 |
Ingestible telemetric gastrointestinal capsule imaging system |
| 876.1400 |
胃部pH电极 |
Stomach pH electrode |
| 876.1500 |
内诊镜及附件 |
Endoscope and accessories |
| 876.1620 |
排尿动力学测量系统 |
Urodynamics measurement system |
| 876.1725 |
胃肠运动监测系统 |
Gastrointestinal motility monitoring system |
| 876.1735 |
胃电描记系统 |
Electrogastrography system |
| 876.1800 |
尿流或尿量测量系统 |
Urine flow or volume measuring system |
| C亚部――监测器械（Monitoring Devices） |
| 876.2040 |
遗尿警报器 |
Enuresis alarm |
| D亚部――修复器械（Prosthetic Devices） |
| 876.3350 |
阴茎膨胀式植入物 |
Penile inflatable implant |
| 876.3630 |
阴茎刚性植入物 |
Penile rigidity implant |
| 876.3750 |
睾丸假体 |
Testicular prosthesis |
| E亚部――手术器械（Surgical Devices） |
| 876.4020 |
光纤式输尿管导管 |
Fiberoptic light ureteral catheter |
| 876.4270 |
结肠造口杆 |
Colostomy rod |
| 876.4300 |
内窥镜式电外科装置及附件 |
Endoscopic electrosurgical unit and accessories |
| 876.4370 |
肠胃病学－泌尿学排泄器 |
Gastroenterology-urology evacuator |
| 876.4440 |
痔结扎器 |
Hemorrhoidal ligator |
| 876.4480 |
电动液压式碎石器 |
Electrohydraulic lithotriptor |
| 876.4500 |
机械式碎石器 |
Mechanical lithotriptor |
| 876.4530 |
肠胃病学－泌尿学光纤式牵引器 |
Gastroenterology-urology fiberoptic retractor |
| 876.4560 |
Ribdam排尿器 |
Ribdam |
| 876.4590 |
联锁尿道探子 |
Interlocking urethral sound |
| 876.4620 |
输尿管展伸器 |
Ureteral stent |
| 876.4650 |
水喷式肾结石排除系统 |
Water jet renal stone dislodger system |
| 876.4680 |
输尿管结石排除器 |
Ureteral stone dislodger |
| 876.4730 |
手动肠胃病学－泌尿学手术器械及附件 |
Manual gastroenterology-urology surgical instrument and accessories |
| 876.4770 |
尿道刀 |
Urethrotom |
| 876.4890 |
泌尿科工作台及附件 |
Urological table and accessories |
| F亚部 ――治疗器械（Therapeutic Devices） |
| 876.5010 |
胆道导管及附件 |
Biliary catheter and accessories |
| 876.5030 |
控制排泄能力的回肠造口导管 |
Continent ileostomy catheter |
| 876.5090 |
耻骨弓上泌尿导管及附件 |
Suprapubic urological catheter and accessories |
| 876.5130 |
泌尿导管及附件 |
Urological catheter and accessories |
| 876.5160 |
男性尿道夹 |
Urological clamp for males |
| 876.5210 |
灌肠工具盒 |
Enema kit |
| 876.5220 |
结肠冲洗系统 |
Colonic irrigation system |
| 876.5250 |
尿液收集器及附件 |
Urine collector and accessories |
| 876.5270 |
植入式电子尿自控设备 |
Implanted electrical urinary continence device |
| 876.5280 |
植入机械式/液压式尿自控设备 |
Implanted mechanical/hydraulic urinary continence device |
| 876.5310 |
非植入式外围电子自控设备 |
Nonimplanted, peripheral electrical continence device |
| 876.5320 |
非植入式电子自控设备 |
Nonimplanted electrical continence device |
| 876.5365 |
食管扩张器 |
Esophageal dilator |
| 876.5450 |
直肠扩张器 |
Rectal dilator |
| 876.5470 |
输尿管扩张器 |
Ureteral dilator |
| 876.5520 |
尿道扩张器 |
Urethral dilator |
| 876.5540 |
血液存取设备及附件 |
Blood access device and accessories |
| 876.5600 |
血液透析用吸附剂可再生的透析液传送系统 |
Sorbent regenerated dialysate delivery system for hemodialysis |
| 876.5630 |
腹膜透析系统及附件 |
Peritoneal dialysis system and accessories |
| 876.5665 |
血液透析用水净化系统 |
Water purification system for hemodialysis |
| 876.5820 |
血液透析系统及附件 |
Hemodialysis system and accessories |
| 876.5830 |
带一次性插入物（Kiil型）的吸引透析器 |
Hemodialyzer with disposable insert （Kiil type） |
| 876.5860 |
高渗透型血液透析系统 |
High permeability hemodialysis system |
| 876.5870 |
吸附剂血液灌注系统 |
Sorbent hemoperfusion system |
| 876.5880 |
隔离的肾灌注与输送系统及附件 |
Isolated kidney perfusion and transport system and accessories |
| 876.5885 |
人体外组织与细胞培养加工应用的组织培养介质 |
Tissue culture media for human ex vivo tissue and cell culture processing applications |
| 876.5895 |
造口冲洗器 |
Ostomy irrigator |
| 876.5900 |
造口术袋及附件 |
Ostomy pouch and accessories |
| 876.5920 |
失禁用保护外衣 |
Protective garment for incontinence |
| 876.5955 |
腹膜－静脉分流管 |
Peritoneo-venous shunt |
| 876.5970 |
疝气支撑物 |
Hernia support |
| 876.5980 |
胃肠管及附件 |
Gastrointestinal tube and accessories |
| 876.5990 |
体外震波碎石机 |
Extracorporeal shock wave lithotripter |
