510(k) Report

510(k) · Cleared

Cleared

Realhand High Dexterity Instruments

K072715510(k) SpecialCleared Oct 16, 200721-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

Novare Surgical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 16, 2007 as substantially equivalent to K071488 (Novare Surgical Systems, Inc., 2007) and 3 other predicates after a 21-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.

Decided
Oct 16, 2007
Review
21 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K910831 (1991). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2022: 1 descendant clearedK910831 · Endopath Surgical Instruments · Symbiosis Corp. · 1991K984240 · Endopath Endoscopic Instruments · Ethicon Endo-Surgery, Inc. · 1999 · recalledK043541 · Endolink True Movement System · Novare Surgical Systems, Inc. · 2005K071488 · Realhand High Dexterity (HD) Instruments · Novare Surgical Systems, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 1 descendant K071488 · Realhand High Dexterity (HD) Instruments · Novare Surgical Systems, Inc. · 2007K043541 · Endolink True Movement System · Novare Surgical Systems, Inc. · 2005K984240 · Endopath Endoscopic Instruments · Ethicon Endo-Surgery, Inc. · 1999 · recalledK910831 · Endopath Surgical Instruments · Symbiosis Corp. · 19910
  1. Root · 4 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
  2. 3 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
  3. 2 generations backK043541 Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005
  4. 1 generation backK071488 Realhand High Dexterity (HD) InstrumentsNovare Surgical Systems, Inc. · 2007
  5. This deviceK072715 Realhand High Dexterity InstrumentsNovare Surgical Systems, Inc. · 2007
  6. Descendant · cites it directly · 0 of its ownK212736 Canady Flex RoboWristUs Medical Innovations, LLC · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K212736Canady Flex RoboWristUs Medical Innovations, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K910831Endopath Surgical InstrumentsSymbiosis Corp.1991—
−3K984240Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc.19991
−2K043541Endolink True Movement SystemNovare Surgical Systems, Inc.2005—
−1K071488Realhand High Dexterity (HD) InstrumentsNovare Surgical Systems, Inc.2007—
0 (this device)K072715Realhand High Dexterity InstrumentsNovare Surgical Systems, Inc.2007—
+1K212736Canady Flex RoboWristUs Medical Innovations, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K072715, 1991–2022Source: 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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (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
*K071488Realhand High Dexterity (HD) Instruments
Summary page 2
…35 * Endolink "RealHand" Articulating Instruments, K071488 - Novare Surgical Systems, Inc., and Endolink "True Movement" Articulating Instruments, K043541 - Novare Surgical…
Novare Surgical Systems, Inc.2007—
*K043541Endolink True Movement System
Summary page 2
…* Endolink "RealHand" Articulating Instruments, K071488 - Novare Surgical Systems, Inc., and Endolink "True Movement" Articulating Instruments, K043541 - Novare Surgical Systems, Inc. * Pajunk Modular Handled Instruments, K033249 * Endopath Endoscopic I…
Novare Surgical Systems, Inc.2005—
*K033249Pajunk Modular Handle Instruments
Summary page 2
…, Inc., and Endolink "True Movement" Articulating Instruments, K043541 - Novare Surgical Systems, Inc. * Pajunk Modular Handled Instruments, K033249 * Endopath Endoscopic Instruments, K984240 Device Description: A new electroconductive pathway was added.…
Pajunk GmbH2004—
*K984240Endopath Endoscopic Instruments
Summary page 2
…ulating Instruments, K043541 - Novare Surgical Systems, Inc. * Pajunk Modular Handled Instruments, K033249 * Endopath Endoscopic Instruments, K984240 Device Description: A new electroconductive pathway was added. This change consists of two basic modifications to the…
Ethicon Endo-Surgery, Inc.19991

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212736Canady Flex RoboWristUs Medical Innovations, LLC20220

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?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K212736 (Us Medical Innovations, LLC, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

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

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The RealHand Tm High Dexterity (HID) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

Indications for use as stated in the FDA summary.

More from Novare Surgical Systems, Inc.

9 FDA decisions under this applicant name. See the company

  • K071488Realhand High Dexterity (HD) InstrumentsNovare Surgical Systems, Inc. · 2007
  • K043541Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005
  • K032589Enclose II Anastomosis Assist DeviceNovare Surgical Systems, Inc. · 2003
  • K023682Enclose Anastomosis Assist DeviceNovare Surgical Systems, Inc. · 2003
  • K010727Flexline ClampNovare Surgical Systems, Inc. · 2002

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The GCJ category page

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https://510kreport.com/device/K072715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072715: Realhand High Dexterity Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072715

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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