510(k) Report

510(k) · Cleared

Cleared

Flexscope

K961536510(k) TraditionalCleared Sep 18, 1996149-day reviewClass II21 CFR 876.1500

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

Matrix Medica, Inc. · GDB Endoscope, Fiber Optic

Cleared on Sep 18, 1996 as substantially equivalent to K850393 (Microvasive, 1985) and 1 other predicate after a 149-day review. Its family tree reaches back 1 generation to 1985.

Decided
Sep 18, 1996
Review
149 days
Class
Class II
Product code
GDB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K850393 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 1 other ancestorK850393 · Flexible Fiberoptic Endoscope · Microvasive · 19851986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K850393 · Flexible Fiberoptic Endoscope · Microvasive · 19850
  1. Root · 1 generation backK850393 Flexible Fiberoptic EndoscopeMicrovasive · 1985
  2. This deviceK961536 FlexscopeMatrix Medica, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
FIG. 1 — Lineage of K961536, 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K850393Flexible Fiberoptic Endoscope
Summary page 1
…MatRix Medical, Inc. 14055 Grand Avenue Suite D Burnsville, MN 55337 (612) 892-0822 Contact Amjad Ahmad President Predicate Devi ‘Endoscopes from: . Microvasive, Inc. K850393 . Codman & Shurtleff K871978 Device [ . The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visua…
Microvasive1985—
*K871978Codman Flexible Endoscope
Summary page 1
…rand Avenue Suite D Burnsville, MN 55337 (612) 892-0822 Contact Amjad Ahmad President Predicate Devi ‘Endoscopes from: . Microvasive, Inc. K850393 . Codman & Shurtleff K871978 Device [ . The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities…
Codman & Shurtleff, Inc.1987—

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.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All GDB devices

GDB Endoscope, Fiber Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDB

FDA has decided no GDB device since 2007.

Median 510(k) review, days · GDB

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

Recalls per year · GDB

No recall names GDB since 2007.

Adverse event reports per year · GDB

1in 2020

2010: 32011: 32012: 12013: 12017: 12020: 1
2007high 3 (2010) · low 0 (2007)2025

MAUDE reports naming product code GDB, 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—03
20110—03
20120—01
20130—01
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The FlexScope is intended to be used for visualization of tissue in general surgical applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Matrix Medica, Inc.

14 FDA decisions under this applicant name. See the company

  • K923693KlormanMatrix Medica, Inc. · 1996
  • K921982Matrx Hope (R) 5 ResuscitatorMatrix Medica, Inc. · 1994
  • K915353Matrx Medical Maximizer 1000 and 2000 Vacuum PumpMatrix Medica, Inc. · 1991
  • K912661Matrx, Pyramid Triangle BandageMatrix Medica, Inc. · 1991
  • K900551Matrx Disposable Non-Invasive Gelled Pacing Elec.Matrix Medica, Inc. · 1990

Recent decisions in GDB

The GDB category page

  • K032283Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
  • K935818EndoscopeCuda Products Co. · 1994
  • K882061Olympus GF-UM3/EU-M3Olympus Corp. · 1988
  • K855151Fritch Ophthalmic EndoscopeRegtec · 1986
  • K843900Focuscope Universal SystemMedical Diagnostics, Ca. · 1984

https://510kreport.com/device/K961536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961536: Flexscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961536

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026