Submission Details
| 510(k) Number | K130059 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2013 |
| Decision Date | July 29, 2013 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
Jul 2013
Decision
200d
Days
Class 2
Risk
About This 510(k) Submission
K130059 is an FDA 510(k) clearance for the ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP, a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II — Special Controls, product code PBQ), submitted by Ibi Israel Biomedical Innovations , Ltd. (Chalotte, US). The FDA issued a Cleared decision on July 29, 2013, 200 days after receiving the submission on January 10, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | PBQ — Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Attaching Suture Or Stapling Ligaments Of The Pelvic Floor. |
Manufacturer
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