510(k) Report

510(k) · Cleared

Recalled · 2002

Bvi Sling

K002233510(k) TraditionalCleared Oct 13, 200081-day reviewClass II21 CFR 878.3300Recalls 1

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

Bio-Vascular, Inc. · PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Oct 13, 2000 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Oct 13, 2000
Review
81 days
Class
Class II
Product code
PAJ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared200020052010201520202025
  1. This deviceK002233 Bvi SlingBio-Vascular, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK122306 Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002233Bvi SlingBio-Vascular, Inc.2000—
+1K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K002233, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 11, 2002Not classifiedZ-0352-03OtherA gap in the exterior seal may lead to sterility concerns with the interior pouch.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K122306 (Synovis Surgical Innovations, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PAJ devices

PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Bio-Vascular, Inc.

26 FDA decisions under this applicant name. See the company

  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-TreatedBio-Vascular, Inc. · 2000
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls
  • K981624Flo-ThruBio-Vascular, Inc. · 19983 recalls

Recent decisions in PAJ

The PAJ category page

  • K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc. · 2005

https://510kreport.com/device/K002233 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002233: Bvi Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002233

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026