ARC ENDOCUFF
Endoscopic Access Overtube, Gastroenterology-urology
BODDINGTONS PLASTICS LTD
The following data is part of a premarket notification filed by Boddingtons Plastics Ltd with the FDA for Arc Endocuff.
Pre-market Notification Details
| Device ID | K122565 |
| 510k Number | K122565 |
| Device Name: | ARC ENDOCUFF |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BODDINGTONS PLASTICS LTD UNIT 6 WHEELBARROW PARK ESTATE PATTENDEN LANE Tonbridge, Kent, GB Tn12 9ql |
| Contact | John Bovis |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2012-09-04 |
| Summary: | summary |
NIH GUDID Devices
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