510(k) Report

510(k) · Cleared

Cleared

Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula

K962702510(k) TraditionalCleared Feb 19, 1997222-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 Feb 19, 1997 as substantially equivalent to K944418 (General Surgical Innovations, 1994) and 1 other predicate after a 222-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.

Decided
Feb 19, 1997
Review
222 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944418 (1994). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1998: 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 clearedK944418 · The Spacemaker and the Spacemaker II · General Surgical Innovations · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K944418 · The Spacemaker and the Spacemaker II · General Surgical Innovations · 19940+5
  1. Root · 1 generation backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
  2. This deviceK962702 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
  7. Descendant · 5 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1998: 12009: 12010: 22011: 12012: 12013: 12015: 12017: 12018: 2
1998high 2 (2010) · low 0 (1999)2026

Most influential descendants

Showing 5 of 11 · See all
  • 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
  • K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944418The Spacemaker and the Spacemaker IIGeneral Surgical Innovations1994—
0 (this device)K962702Spacemaker 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
+5K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200910
201020
201110
201210
201310
201510
201710
201820
FIG. 1 — Lineage of K962702, 1994–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K944418The Spacemaker and the Spacemaker II
Summary page 1
…Serial Surgical Balloon Dissector with Visualization and Cannula, Class II 10.4 Commen Name Surgical Balloon Dissector with or without Cannula 10.5 Predicate devices K944418 Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula, Class I K951878 Spacemaker® and Spacemaker® II Surgical B…
General Surgical Innovations1994—
*K951878Spacemaker, II Surgical Balloon Dissector with and Without a Cannula
Summary page 1
…Name Surgical Balloon Dissector with or without Cannula 10.5 Predicate devices K944418 Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula, Class I K951878 Spacemaker® and Spacemaker® II Surgical Balloon Di.ssector with and without a Cannula, Class II 01/16/97 23 (page number from or…
General Surgical Innovations1995—

Also cleared against K944418: 1 other device →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations199810

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K973046 (General Surgical Innovations, 1998) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K944418.

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—

What is it indicated for?

The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K944418

1 other device cites the same predicate.

  • K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations · 1998

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
  • K961356Mammary SizerGeneral Surgical Innovations · 1996

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K962702 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962702

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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