510(k) Report

510(k) · Cleared

Cleared

Spacemaker, II Surgical Balloon Dissector with and Without a Cannula

K951878510(k) TraditionalCleared Jun 29, 199584-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

General Surgical Innovations · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 29, 1995 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Jun 29, 1995
Review
84 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

14 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1997: 2 descendants cleared2008: 1 descendant cleared2018: 2 descendants cleared2009: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951878 Spacemaker, II Surgical Balloon Dissector with and Without a CannulaGeneral Surgical Innovations · 1995
  2. Descendant · cites it directly · 11 of its ownK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
  3. Descendant · cites it directly · 10 of its ownK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
  4. Descendant · 2 generations on · 9 of its ownK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
  5. Descendant · 3 generations on · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
  6. Descendant · 4 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12008: 12009: 12010: 22011: 12012: 12013: 12015: 12017: 12018: 2
1997high 2 (1997) · low 0 (1999)2026

Most influential descendants

Showing 5 of 14 · See all
  • K962702Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with…General Surgical Innovations · 1997 · cites it directly11descendants
  • K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations · 1998 · cites it directly10descendants
  • K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009 · 2 generations on9descendants
  • K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · 3 generations on7descendants
  • K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951878Spacemaker, II Surgical Balloon Dissector with and Without a CannulaGeneral Surgical Innovations1995—
+1K962702Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization…General Surgical Innovations1997—
+1K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon…General Surgical Innovations1998—
+2K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie2009—
+3K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.2010—
+4K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.20102

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200810
200910
201020
201110
201210
201310
201510
201710
201820
FIG. 1 — Lineage of K951878, 1995–2018Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K962702Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with…General Surgical Innovations199711
K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations199810
K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations19971

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, K962702 (General Surgical Innovations, 1997) has gone furthest, with 11 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.

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—

More from General Surgical Innovations

14 FDA decisions under this applicant name. See the company

  • K983318Fixation SystemGeneral Surgical Innovations · 1999
  • K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations · 1998
  • K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997
  • K970201Gsi Cannula with IntroducerGeneral Surgical Innovations · 1997
  • K962702Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and…General Surgical Innovations · 1997

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https://510kreport.com/device/K951878 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951878

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026