Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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030
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Date of Entry 01/15/2013
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FR Recognition Number
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9-39
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Standard | |
ISO 8600-5 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
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Scope/AbstractThis part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system. |
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Extent of Recognition
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Transition Period
FDA recognition of ISO 8600-5 First edition 2005-03-15 [Rec# 9-39] will be superseded by recognition of ISO 8600-5 Second Edition 2020-10 [Rec# 9-131]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-39] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-39] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
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Regulation Number |
Device Name |
Device Class |
Product Code |
§884.1690 |
Falloposcope |
Class 2 |
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, 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 |
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Relevant FDA Guidance and/or Supportive Publications*
Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
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*These are provided as examples and others may be applicable. |