EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS— 510(k) K083499

Clearance details

Applicant

Coloplast A/S

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2008-11-25

Decision date

2009-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

• K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM2012-12-13
• K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION2012-07-20
• K112842 — AMS ELEVATE PC2011-10-25
• K103426 — LITE PELVIC FLOOR REPAIR KITS2011-09-14
• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08

• K262045 — Luja Soft2026-07-07
• K221874 — Altis Single Incision Sling System2023-02-15
• K220420 — Saffron Fixation System2022-06-10
• K191536 — Biatain Silicone Ag2020-02-21
• K181811 — ReTrace Ureteral Access Sheath2018-09-07

Injury

1,061

Total

1,061

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →