Cleared Abbreviated

BOSTON SCIENTIFIC SURGICAL MESH (K081275) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081275 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
114d
Days
Class 2
Risk

K081275 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC SURGICAL MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on August 27, 2008 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K081275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date August 27, 2008
Days to Decision 114 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

All 19
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K081275.
Altis Single Incision Sling System (519650)
K242473 · Coloplast Corp. · Oct 2024
Altis Single Incision Sling System
K221874 · Coloplast A/S · Feb 2023
Desara One Single Incision Sling System, 1 Pack
K191416 · Caldera Medical, Inc. · Feb 2020
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
K123179 · C.R. Bard, Inc. · Nov 2012
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607 · C.R. Bard, Inc. · Nov 2009