510(k) Report

510(k) · Cleared

Cleared

Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros

K011849510(k) TraditionalCleared Dec 10, 2001180-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

Circon Video · FGB Ureteroscope And Accessories, Flexible/Rigid

Cleared on Dec 10, 2001 after a 180-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it.

Decided
Dec 10, 2001
Review
180 days
Class
Class II
Product code
FGB
Recalls
None
Predicates
0

26 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2020: 3 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2018: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2019: 5 descendants cleared2021: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK011849 Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633…Circon Video · 2001
  2. Descendant · cites it directly · 25 of its ownK052044 Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 2005
  3. Descendant · 2 generations on · 23 of its ownK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
  4. Descendant · 3 generations on · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
  5. Descendant · 4 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
  6. Descendant · 5 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12010: 12013: 12014: 12015: 12016: 12017: 12018: 12019: 52020: 32021: 22024: 32025: 12026: 2
2005high 5 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 26 · See all
  • K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 2005 · cites it directly25descendants
  • K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007 · 2 generations on23descendants
  • K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · 3 generations on22descendants
  • K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 4 generations on20descendants
  • K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 5 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642)…Circon Video2001—
+1K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation2005—
+2K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.2007—
+3K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.2009—
+4K123151Endosee Model 8000 U-ScopeEndosee Corp2013—
+5K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201010
201310
201410
201510
201610
201710
201810
201950
202030
202120
202430
202510
202620
FIG. 1 — Lineage of K011849, 2001–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

Top candidate predicates for a new FGB device

  1. #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation200525
K200369OES Elite Ureteroscopes and AccessoriesOlympus Winter & Ibe GmbH20200

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, K052044 (Acmi Corporation, 2005) has gone furthest, with 25 descendants of its own.

How does its category compare?

All FGB devices

FGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGB

17in 2025

2012: 22013: 12014: 22015: 12017: 22018: 42019: 22020: 22021: 32022: 52023: 82024: 162025: 172026 (partial year): 9
2007high 17 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGB

134in 2025

2018: 191 days median2021: 191 days median2022: 205 days median2023: 183 days median2024: 217 days median2025: 134 days median2026 (partial year): 140 days median
2007high 217 (2024) · low 134 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGB

15in 2024

2022: 42023: 12024: 152026 (partial year): 1
2007high 15 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGB

1,307in 2025

2007: 62008: 72009: 42010: 202011: 172012: 112013: 82014: 122015: 162016: 352017: 1422018: 1182019: 2072020: 4022021: 3252022: 4552023: 4582024: 5722025: 1,307
2007high 1,307 (2025) · low 4 (2009)2025

MAUDE reports naming product code FGB, 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—06
20080—07
20090—04
20100—020
20110—017
20122—011
20131—08
20142—012
20151—016
20160—035
20172—0142
201841910118
20192—0207
20202—0402
202131910325
202252054455
202381831458
20241621715572
20251713401,307
202691401—

What is it indicated for?

The intended use for these Ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, “Sterility Information.”

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Circon Video

14 FDA decisions under this applicant name. See the company

  • K012758Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,Circon Video · 2002
  • K011876Dolphin II Fluid Management System, Model Dol-2Circon Video · 2002
  • K012929Flexible Pediatric Cystoureteroscope, Model Aur- 735Circon Video · 2001
  • K012951Apn-2 Usa Series Flexible CholedochoscopeCircon Video · 2001
  • K012925Dur-8, Models Dur-8Circon Video · 2001

Recent decisions in FGB

The FGB category page

  • K260708Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed…Vein 360 · 2026
  • K261447CVAC® Aspiration SystemCalyxo, Inc. · 2026
  • K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2026
  • K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation · 2026
  • K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K011849 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011849: Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011849

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026