510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath

K072521510(k) TraditionalCleared Nov 20, 200774-day reviewClass II21 CFR 876.1500Recalls 1

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

Cook Urological, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope

Cleared on Nov 20, 2007 as substantially equivalent to K925128 (KARL STORZ Endoscopy-America, Inc., 1993) and 3 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1999. It has been recalled once.

Decided
Nov 20, 2007
Review
74 days
Class
Class II
Product code
FFS
Recalls
1
Predicates
4

Its longest line of descent runs back 3 generations to K990775 (1999). 10 ancestors in all, the oldest K922826 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1993: 2 other ancestors2003: 3 other ancestors1996: 1 other ancestorK990775 · Ureteral Access Sheath Set · Applied Medical Resources · 1999K993650 · Ureteral Access Sheath Set - New Models · Applied Medical Resources · 1999K030642 · Deflecting Ureteral Access Sheath · Applied Medical Resources Corp. · 20031990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors K030642 · Deflecting Ureteral Access Sheath · Applied Medical Resources Corp. · 2003K993650 · Ureteral Access Sheath Set - New Models · Applied Medical Resources · 1999K990775 · Ureteral Access Sheath Set · Applied Medical Resources · 19990
  1. Root · 3 generations backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
  2. 2 generations backK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
  3. 1 generation backK030642 Deflecting Ureteral Access SheathApplied Medical Resources Corp. · 2003
  4. This deviceK072521 Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K990775Ureteral Access Sheath SetApplied Medical Resources1999—
−2K993650Ureteral Access Sheath Set - New ModelsApplied Medical Resources1999—
−1K030642Deflecting Ureteral Access SheathApplied Medical Resources Corp.2003—
0 (this device)K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199610
200330
200510
FIG. 1 — Lineage of K072521, 1999–2007Source: 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 FFS? 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? (4)

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
*K925128The Karl Storz 11274 Series Flexible Fiberscope
Summary page 1
…tions for use and technology to existing predicate devices incommercial distribution. Specifically, The Cook® Fiber Optic Bundle is similar to the Karl Storz Fiberscope (K925128/B) manufactured by Kail Storz Endoscope and the Flexible Fiber Optic Bundle(K922826) manufactured by Optimed Technologies, Incorp…
KARL STORZ Endoscopy-America, Inc.1993—
*K922826Flexible Fiber Optic Endoscope
Summary page 1
…. Specifically, The Cook® Fiber Optic Bundle is similar to the Karl Storz Fiberscope (K925128/B) manufactured by Kail Storz Endoscope and the Flexible Fiber Optic Bundle(K922826) manufactured by Optimed Technologies, Incorporated. The Deflecting Flexor Access Sheath is similar to the Flexor DL Ureteral Acc…
Optimed Technologies, Inc.19931
*K043418Cook Pediatric Flexor Ureteral Access Shealth
Summary page 1
…e Fiber Optic Bundle(K922826) manufactured by Optimed Technologies, Incorporated. The Deflecting Flexor Access Sheath is similar to the Flexor DL Ureteral Access Sheath (K04341 8) manufactured by Cook Urological, Incorporated and the Fadte' Plus Deflecting Renal Access Sheath (K030642) manufactured by Appli…
Cook Urological, Inc.20051
*K030642Deflecting Ureteral Access Sheath
Summary page 1
…ss Sheath is similar to the Flexor DL Ureteral Access Sheath (K04341 8) manufactured by Cook Urological, Incorporated and the Fadte' Plus Deflecting Renal Access Sheath (K030642) manufactured by Applied Medical. Device Description: The Cook® Fiber Optic Bundle isa small diameter fiber optic consisting o…
Applied Medical Resources Corp.2003—

Also cleared against K925128: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 3, 2017Class IIZ-2540-2017Device DesignCook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • 1 other device also cites its predicate K925128.

How does its category compare?

All FFS devices

FFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FFS

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFS

74in 2007

2007: 74 days median
2007high 74 (2007)2026

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

Recalls per year · FFS

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FFS

5in 2024

2007: 122008: 172009: 142010: 52011: 72012: 42013: 102014: 52015: 42016: 72017: 192018: 192019: 172020: 562021: 572022: 102023: 62024: 5
2007high 57 (2021) · low 0 (2025)2025

MAUDE reports naming product code FFS, 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
2007374112
20080—017
20090—014
20100—05
20110—07
20120—04
20130—010
20140—05
20150—04
20160—07
20170—019
20180—019
20190—017
20200—056
20210—057
20220—010
20230—06
20240—05
20250—00
20260—0—

What is it indicated for?

The Cook®Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

Indications for use as stated in the FDA summary.

Also cleared against K925128

1 other device cites the same predicate.

  • K232911KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible…Karl Storz Endovision, Inc. · 2024

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in FFS

The FFS category page

  • K061622PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007
  • K063309Tru-CableTruphatek International, Ltd. · 2007
  • K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
  • K023633Sovis Optique's Endoscopic CableSovis Optique · 2002
  • K001698Micro Link Endoscopic Fiber Cable, Model B1-90159Cogent Light Technologies, Inc. · 2000

https://510kreport.com/device/K072521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072521: Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072521

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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