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