PINNACLE PELVIC FLOOR REPAIR KITS— 510(k) K071957

Clearance details

Applicant

Boston Scientific Corp

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2007-07-16

Decision date

2007-11-08

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Marlboro, MA, 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

• K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more2024-10-18
• K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)2023-08-19
• K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary2015-11-20
• K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System2015-08-05
• K150303 — XXL Vascular Balloon Dilatation Catheter2015-06-15

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-1624-2018 — PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.Class II·Terminated·Boston Scientific Corporation·20180212
• Z-1625-2018 — PFR Kit- Pinnacle, Posterior; Model #M0068317100. 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 K071957.