Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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9-110
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Standard | |
ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
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Scope/AbstractISO 8600-1:2015 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
Hysteroscope (And Accessories) |
Class 2 |
HIH |
§884.1720 |
Laparoscope, Gynecologic (And Accessories) |
Class 2 |
HET |
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§884.1690 |
Falloposcope |
Class 2 |
MKO |
§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 |
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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. |