510(k) Report

510(k) · Cleared

Cleared

PBN Fallopian Tube Catheter System

K000620510(k) TraditionalCleared Oct 30, 2000249-day reviewClass II21 CFR 884.4530

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

Medical Device Technologies, Inc. · MDG System, Intrafallopian Cannula

Cleared on Oct 30, 2000 after a 249-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 30, 2000
Review
249 days
Class
Class II
Product code
MDG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K000620Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MDG devices

MDG System, Intrafallopian Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDG

FDA has decided no MDG device since 2007.

Median 510(k) review, days · MDG

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

Recalls per year · MDG

No recall names MDG since 2007.

Adverse event reports per year · MDG

No MAUDE report names MDG since 2007.

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—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K000620: PBN Fallopian Tube Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000620

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