510(k) Report

510(k) · Cleared

Cleared

Flexible Fiberoptic Endoscope

K850393510(k) TraditionalCleared Jun 4, 1985123-day review

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

Microvasive

Cleared on Jun 4, 1985 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 4, 1985
Review
123 days
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK850393 Flexible Fiberoptic EndoscopeMicrovasive · 1985
  2. Descendant · cites it directly · 0 of its ownK961536 FlexscopeMatrix Medica, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K961536FlexscopeMatrix Medica, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850393Flexible Fiberoptic EndoscopeMicrovasive1985—
+1K961536FlexscopeMatrix Medica, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K850393, 1985–1996Source: 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.

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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
K961536FlexscopeMatrix Medica, Inc.19960

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.

What does this lineage say?

  • Of its descendants, K961536 (Matrix Medica, Inc., 1996) has gone furthest, with 0 descendants of its own.

More from Microvasive

18 FDA decisions under this applicant name. See the company

  • K872771Low Profile GastrostomyMicrovasive · 1987
  • K870705Thermal CoagulatorMicrovasive · 1987
  • K861309Jejunal Feeding TubeMicrovasive · 1986
  • K861323Replacement Gastrostomy TubeMicrovasive · 198621 recalls
  • K860589Inflator/Deflator Piston SyringeMicrovasive · 1986

https://510kreport.com/device/K850393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850393: Flexible Fiberoptic Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850393

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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