| ASTM F1992 -99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 9-53 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Shanil Haugen FDA/OMPT/CDRH/ODE/DRGUD/ULDB/ 301-796-0301 shanil.haugen@fda.hhs.gov |
This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing.
This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.4400 | Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | GEI |
| §876.5365 | Dilator, Esophageal | Class 2 | KNQ |
| §876.4730 | Snare, Non-Electrical | Class 1 | FGX |
| §876.4680 | Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | FFL |
| §876.4680 | Dislodger, Stone, Flexible | Class 2 | FGO |
| §876.4300 | Electrode, Flexible Suction Coagulator | Class 2 | FEH |
| §876.4300 | Forceps, Biopsy, Electric | Class 2 | KGE |
| §876.4300 | Snare, Flexible | Class 2 | FDI |
| §876.4300 | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class 2 | KNS |
| §876.1500 | Accessories, Cleaning Brushes, For Endoscope | Class 1 | MNL |
| §876.1500 | Apparatus, Pneumoperitoneum, Automatic | Class 2 | FDP |
| §876.1500 | Carrier, Sponge, Endoscopic | Class 2 | FGS |
| §876.1500 | Device, Measuring, For Panendoscope | Class 1 | FDY |
| §876.1500 | Endoscope Holder | Class 2 | OCV |
| §876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | Class 2 | OCZ |
| §876.1500 | Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | OCY |
| §876.1500 | Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | FBK |
| §876.1500 | Endoscopic Irrigation/Suction System | Class 2 | OCX |
| §876.1500 | Mini Endoscope, Gastroenterology-Urology | Class 2 | ODF |
| §876.1500 | Needle, Pneumoperitoneum, Simple | Class 2 | FHP |
| §876.1500 | Obturator, For Endoscope | Class 2 | FEC |
| §876.1500 | Pneumoperitoneum Needle | Class 2 | FHO |
| §876.1075 | Biopsy Needle | Class 2 | FCG |
| §876.1075 | Forceps, Biopsy, Non-Electric | Class 1 | FCL |
| Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff, Issued January 2016. |