PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM— 510(k) K122459

Clearance details

Applicant

Boston Scientific Corporation

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2012-08-13

Decision date

2012-12-13

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Marlboro, MA, US

• 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
• K102815 — SURELIFT PROLAPSE SYSTEM2011-07-07

• K262151 — SpaceOAR Flex System2026-09-11
• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
• K261488 — OBSIDIO Conformable Embolic2026-07-24
• K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

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 →

• Z-1622-2018 — Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.Class II·Terminated·Boston Scientific Corporation·20180212
• Z-1623-2018 — Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.Class II·Terminated·Boston Scientific Corporation·20180212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122459.