510(k) Report

FDA product code · Obstetrics and gynecology

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

PAJClass II21 CFR 878.3300510(k) required2 decisions since 20000 recalls

2 FDA decisions since 2000. No recall names this code. The most-cited predicate is K002233, named by 1 later device.

Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of PAJ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PAJ

FDA has decided no PAJ device since 2007.

Median 510(k) review, days · PAJ

Too few PAJ 510(k)s in any year since 2007 to give a median.

Recalls per year · PAJ

No recall names PAJ since 2007.

Adverse event reports per year · PAJ

2in 2019

2013: 612014: 662015: 2862016: 2672017: 962018: 92019: 2
2007high 286 (2015) · low 0 (2007)2025

MAUDE reports naming product code PAJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—061
20140—066
20150—0286
20160—0267
20170—096
20180—09
20190—02
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PAJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PAJ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PAJ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K002233Bvi SlingBio-Vascular, Inc. · 20001cites it
  • K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 20051cites it

Which PAJ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 20054generations

What has FDA decided in PAJ lately?

  • K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 2005
  • K002233Bvi SlingBio-Vascular, Inc. · 20001 recall

All 2 PAJ decisions →

Related product codes

Other codes under 21 CFR 878.3300.

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