510(k) Report

510(k) · Cleared

Recalled · Class I · 2012

Vycor Surgical Access Systems

K060973510(k) TraditionalCleared Jul 26, 2006107-day reviewClass II21 CFR 882.4800Recalls 1 (1 Class I)

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

Vycor Medical, LLC · GZT Retractor, Self-Retaining, For Neurosurgery

Cleared on Jul 26, 2006 as substantially equivalent to K043602 (Medtronic Sofamor Danek, 2005) and 3 other predicates after a 107-day review. Its family tree reaches back 2 generations to 2000. 1 of the 17 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once, including a Class I recall.

Decided
Jul 26, 2006
Review
107 days
Class
Class II
Product code
GZT
Recalls
1 (1 Class I)
Predicates
4

Its longest line of descent runs back 2 generations to K002931 (2000). 6 ancestors in all, the oldest K830332 (1983). 10 later devices descend from it, 2 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1989: 2 other ancestors1983: 1 other ancestor2004: 1 other ancestor2021: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2019: 2 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant clearedK002931 · Metrx System · Medtronic Sofamor Danek, Inc. · 2000K043602 · Quadrant Retractor System · Medtronic Sofamor Danek · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K043602 · Quadrant Retractor System · Medtronic Sofamor Danek · 2005K002931 · Metrx System · Medtronic Sofamor Danek, Inc. · 20000+5
  1. Root · 2 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
  2. 1 generation backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
  3. This deviceK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006
  4. Descendant · cites it directly · 8 of its ownK120691 Brain PortNico Corporation · 2012 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
  6. Descendant · 3 generations on · 3 of its ownK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
  7. Descendant · 4 generations on · 2 of its ownK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12017: 12019: 22020: 22021: 12023: 12025: 1
2012high 2 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K120691Brain PortNico Corporation · 2012 · cites it directly8descendants
  • K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019 · 2 generations on4descendants
  • K191861Aurora Surgiscope SystemRebound Therapeutics · 2019 · 3 generations on3descendants
  • K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 2020 · 4 generations on2descendants
  • K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002931Metrx SystemMedtronic Sofamor Danek, Inc.2000—
−1K043602Quadrant Retractor SystemMedtronic Sofamor Danek2005—
0 (this device)K060973Vycor Surgical Access SystemsVycor Medical, LLC2006—
+1K120691Brain PortNico Corporation20122
+2K182211Aurora Surgiscope SystemRebound Therapeutics Corporation2019—
+3K191861Aurora Surgiscope SystemRebound Therapeutics2019—
+4K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control…Rebound Therapeutics20201
+2K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198920
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201710
201920
202020
202110
202310
202510
FIG. 1 — Lineage of K060973, 2000–2025Source: 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.

1 device in this family has a Class I recall. 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 GZT device

  1. #1 K252995 Durashield Device Kitscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K043602Quadrant Retractor System
Summary page 2
…evice [21 CFR 807.92(a)(3)J The predicate devices are listed as follows: For Spinal Indications: * Medtronic -Mast Quadrant Retractor System -K043602 For Brain Indications: * V. Mueller-Brain Retractor -K895395 * Budde Halo Retractor - K830332…
Medtronic Sofamor Danek2005—
*K895395V. Mueller Rhoton Self-Retaining Brain Retractor
Summary page 2
…For Spinal Indications: * Medtronic -Mast Quadrant Retractor System -K043602 For Brain Indications: * V. Mueller-Brain Retractor -K895395 * Budde Halo Retractor - K830332 * Compass Stereotactic System -Retractor - K896156 Conclusion […
Baxter Healthcare Corp1989—
*K830332Budde-Halo Retractor
Summary page 2
…edtronic -Mast Quadrant Retractor System -K043602 For Brain Indications: * V. Mueller-Brain Retractor -K895395 * Budde Halo Retractor - K830332 * Compass Stereotactic System -Retractor - K896156 Conclusion [21 CFR 807.92(b)(3)J We believe the difference…
Ohio Medical Instrument Co., Inc.19831
*K896156Compass (TM) Stereotactic Retractor System
Summary page 2
…ndications: * V. Mueller-Brain Retractor -K895395 * Budde Halo Retractor - K830332 * Compass Stereotactic System -Retractor - K896156 Conclusion [21 CFR 807.92(b)(3)J We believe the differences between the subject device and predicate device are minor and concl…
Stereotactic Medical Systems, Inc.1989—

Also cleared against K043602: 4 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K120691Brain PortNico Corporation20128
K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…Vycor Medical, Inc.20210

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 21, 2012Class IZ-0673-2013Equipment maintenanceVycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K120691 (Nico Corporation, 2012) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K043602.

How does its category compare?

All GZT devices

GZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZT

1in 2022

2007: 22009: 12010: 12011: 12012: 22015: 12016: 12017: 32018: 12020: 12021: 12022: 12026 (partial year): 1
2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZT

280in 2017

2017: 280 days median
2007high 280 (2017)2026

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

Recalls per year · GZT

1in 2012

2007: 12012: 1, 1 Class I
2007high 1 (2007) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GZT

1in 2025

2009: 12010: 42011: 42012: 62013: 122014: 162015: 42016: 52017: 92018: 32019: 52020: 32021: 22022: 42023: 22024: 82025: 1
2007high 16 (2014) · low 0 (2007)2025

MAUDE reports naming product code GZT, 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
20072—10
20080—00
20091—01
20101—04
20111—04
20122—1 (1)6
20130—012
20140—016
20151—04
20161—05
2017328009
20181—03
20190—05
20201—03
20211—02
20221—04
20230—02
20240—08
20250—01
20261—0—

What is it indicated for?

To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

Indications for use as stated in the FDA summary.

Also cleared against K043602

4 other devices cite the same predicate.

  • K151104Otelo LLSpineart · 2016
  • K113273Spotlight Access SystemJohnson & Johnson · 2012
  • K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009
  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006

Recent decisions in GZT

The GZT category page

  • K252995Durashield Device KitSurGenTec, LLC · 2026
  • K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc. · 2022
  • K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the…Vycor Medical, Inc. · 2021
  • K202072MindsEye Expandable PortMinnetronix Neuro, Inc. · 2020
  • K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018

https://510kreport.com/device/K060973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060973: Vycor Surgical Access Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060973

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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