FDA-recognized standard · ObGyn/Gastroenterology/Urology
ISO 8600-4: Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
Yes. FDA recognizes ISO 8600-4 Third Edition 2023-01 as recognition 9-146, entered 2023-05-29.
Recognized editions of ISO 8600-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-146 | ISO 8600-4 Third Edition 2023-01 | 2023-05-29 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 8600-4: 21 CFR 874.4680, 21 CFR 874.4710, 21 CFR 874.4760, 21 CFR 876.1300, 21 CFR 876.1310, 21 CFR 876.1330, 21 CFR 876.1500, 21 CFR 884.1630, 21 CFR 884.1640, 21 CFR 884.1690, 21 CFR 884.1720.
Product codes that cite ISO 8600-4
54 FDA product codes cite ISO 8600-4, including EOB, EOQ, EOX, FAJ, FAK.
- EOB Nasopharyngoscope (Flexible Or Rigid)
- EOQ Bronchoscope (Flexible Or Rigid)
- EOX Esophagoscope (Flexible Or Rigid)
- FAJ Cystoscope And Accessories, Flexible/Rigid
- FAK
- FAL
- FAM
- FAN
- FBN Choledochoscope And Accessories, Flexible/Rigid
- FBO
- FBP
- FDA
- FDE
- FDF Colonoscope And Accessories, Flexible/Rigid
- FDR
- FDS Gastroscope And Accessories, Flexible/Rigid
- FDT Duodenoscope And Accessories, Flexible/Rigid
- FDW
- FER
- FGA
- FGB Ureteroscope And Accessories, Flexible/Rigid
- FGC
- FJL
- FTJ
- GCF
- GCG
- GCH
- GCI
- GCJ Laparoscope, General & Plastic Surgery
- GCK
- GCL
- GCP
- GCQ
- GCS
- GDB
- HET Laparoscope, Gynecologic (And Accessories)
- HEW
- HEX
- HIH Hysteroscope (And Accessories)
- KDM
- KYH
- LYK
- MKO
- MOK
- NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
- NMH
- NSI
- NWB
- NWS
- NWT
- ODF
- OHD
- PGD
- QKZ
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.