OPHIRA MINI SLING SYSTEM— 510(k) K110420
Substantially EquivalentPromedon S.A
FDA 510(k) clearance K110420 for OPHIRA MINI SLING SYSTEM, Substantially Equivalent on 2012-05-08. Applicant: Promedon S.A. Device class: 2.
Clearance details
- Applicant
- Promedon S.A
- Product code
- Code PAH
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Piscataway, NJ, US
Recent devices under product code PAH
view all- K242473 — Altis Single Incision Sling System (519650) +2 more
- K221874 — Altis Single Incision Sling System
- K191416 — Desara One Single Incision Sling System, 1 Pack; Desara One Single Incision Sling System, 3 Pack
- K121562 — ALTIS SINGLE INCISION CLING SYSTEM
- K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
Adverse events under product code PAH
product code PAH- Injury
- 886
- Malfunction
- 529
- Total
- 1,415
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.