Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
055
|
Date of Entry 12/21/2020
|
FR Recognition Number
|
9-130
|
Standard | |
ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
|
Scope/AbstractThis document defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. This document does not define general medical terms or other general terms. This document does not define terms that should be defined in other ISO 8600 (all parts). |
|
Extent of Recognition
|
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Transition Period
FDA recognition of ISO 8600-6 First edition 2005-03-15 [Rec# 9-40] will be superseded by recognition of ISO 8600-6 Second edition 2020-09 [Rec# 9-130]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-40] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 9-40] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§874.4680 |
Bronchoscope (Flexible Or Rigid) |
Class 2 |
EOQ |
§874.4710 |
Esophagoscope (Flexible Or Rigid) |
Class 2 |
EOX |
§874.4760 |
Nasopharyngoscope (Flexible Or Rigid) |
Class 2 |
EOB |
§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, 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 |
§884.1630 |
Colposcope (And Colpomicroscope) |
Class 2 |
HEX |
§884.1630 |
Vaginoscope And Accessories |
Class 2 |
MOK |
§884.1640 |
Culdoscope (And Accessories) |
Class 2 |
HEW |
§884.1690 |
Falloposcope |
Class 2 |
MKO |
§884.1690 |
Hysteroscope (And Accessories) |
Class 2 |
HIH |
§884.1720 |
Laparoscope, Gynecologic (And Accessories) |
Class 2 |
HET |
|
Relevant FDA Guidance and/or Supportive Publications*
Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
|
|
*These are provided as examples and others may be applicable. |