Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-38: ISO 8600-3 First edition 1997-07-01 AMENDMENT 1, Optics and optical instruments - Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics`. (ObGyn/Gastroenterology)

Date of Standard: 1997.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Endoscopes and Accessories (GI/GU), Colposcope, Culdoscope, Hysteroscope, Fallopscope, Gynecologic Laparoscope. Breast Ductoscope

Processes Affected:

510(k), PMA, IDE, PDP, HDE, Design Control Input

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Ductoscope, Breast	Class U	MMN
Unclassified	Falloposcope	Class U	MKO

Regulation Number	Device Name	Device Class	Product Code
§876.1500	Angioscope	Class 2	LYK
§876.1500	Anoscope And Accessories	Class 2	FER
§876.1500	Choledochoscope And Accessories, Flexible/Rigid	Class 2	FBN
§876.1500	Colonoscope And Accessories, Flexible/Rigid	Class 2	FDF
§876.1500	Cystoscope And Accessories, Flexible/Rigid	Class 2	FAJ
§876.1500	Cystourethroscope	Class 2	FBO
§876.1500	Duodenoscope And Accessories, Flexible/Rigid	Class 2	FDT
§876.1500	Endoscope And/Or Accessories	Class 2	KOG
§876.1500	Endoscope, Flexible	Class 2	GCQ
§876.1500	Endoscope, Rigid	Class 2	GCM
§876.1500	Enteroscope And Accessories	Class 2	FDA
§876.1500	Kit, Nephroscope	Class 2	FGA
§876.1500	Laparoscope, General & Plastic Surgery	Class 2	GCJ
§876.1500	Resectoscope	Class 2	FJL
§876.1500	Sigmoidoscope And Accessories, Flexible/Rigid	Class 2	FAM
§876.1500	Sigmoidoscope, Rigid, Electrical	Class 2	FAN
§876.1500	Telescope, Rigid, Endoscopic	Class 2	FBP
§876.1500	Ureteroscope And Accessories, Flexible/Rigid	Class 2	FGB
§876.1500	Urethroscope	Class 2	FGC

Regulation Number	Device Name	Device Class	Product Code
§884.1630	Colposcope (And Colpomicroscope)	Class 2	HEX
§884.1630	Vaginoscope And Accessories	Class 2	MOK

Regulation Number	Device Name	Device Class	Product Code
§884.1640	Culdoscope (And Accessories)	Class 2	HEW

Regulation Number	Device Name	Device Class	Product Code
§884.1690	Hysteroscope (And Accessories)	Class 2	HIH

Regulation Number	Device Name	Device Class	Product Code
§884.1720	Laparoscope, Gynecologic (And Accessories)	Class 2	HET