510(k) · Cleared
ClearedSpacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Surgical Innovations · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 16, 1998 as substantially equivalent to K926010 (General Surgical Innovations, 1993) and 9 other predicates after a 154-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Jan 16, 1998
- Review
- 154 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 2 generations to K944418 (1994). 10 ancestors in all, the oldest K926010 (1993). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
- 1 generation backK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
- This deviceK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
- Descendant · cites it directly · 9 of its ownK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- Descendant · 2 generations on · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- Descendant · 3 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009 · cites it directly9descendants
- K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · 2 generations on7descendants
- K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 3 generations on6descendants
- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 4 generations on5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944418 | The Spacemaker and the Spacemaker II | General Surgical Innovations | 1994 | — |
| −1 | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… | General Surgical Innovations | 1997 | — |
| 0 (this device) | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… | General Surgical Innovations | 1998 | — |
| +1 | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| +2 | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| +3 | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | 2 |
| +4 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +4 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K926010 | Surgical Dissector with CannulaSummary page 1…ithout Cannula Spacemaker® Serial Surgical Balloon Dissector w/ or w/o Cannula & w/ or w/o Visualization 4, Common Name Surgical Balloon Dissector 5. Predicate devices K926010 Surgical Dissector with Cannula K944418 Spacemaker® and Spacemaker II Surgical Balloon Dissector and Cannula _ K951878 Spacemak… | 1993 |
| * | K944418 | The Spacemaker and the Spacemaker IISummary page 1…l Balloon Dissector w/ or w/o Cannula & w/ or w/o Visualization 4, Common Name Surgical Balloon Dissector 5. Predicate devices K926010 Surgical Dissector with Cannula K944418 Spacemaker® and Spacemaker II Surgical Balloon Dissector and Cannula _ K951878 Spacemaker® and Spacemaker® II Surgical Balloon D… | 1994 |
| * | K951878 | Spacemaker, II Surgical Balloon Dissector with and Without a CannulaSummary page 1…Surgical Balloon Dissector 5. Predicate devices K926010 Surgical Dissector with Cannula K944418 Spacemaker® and Spacemaker II Surgical Balloon Dissector and Cannula _ K951878 Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Cannula, Class 11 K952278 Reusable Spacemaker® Surg… | 1995 |
| * | K952278 | The Reusable Spacemaker Surgical Balloon Dissector & CannulaSummary page 1…aker® and Spacemaker II Surgical Balloon Dissector and Cannula _ K951878 Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Cannula, Class 11 K952278 Reusable Spacemaker® Surgical Balloon Dissector with Cannula K962702 Spacemaker® Serial Surgical Balloon Dissector with or witho… | 1995 |
| * | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with…Summary page 1…878 Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Cannula, Class 11 K952278 Reusable Spacemaker® Surgical Balloon Dissector with Cannula K962702 Spacemaker® Serial Surgical Balloon Dissector with or without Cannula and with or without Visualization K953377 Tapered Tip Ball… | 1997 |
| * | K953377 | Distention BalloonSummary page 1…ble Spacemaker® Surgical Balloon Dissector with Cannula K962702 Spacemaker® Serial Surgical Balloon Dissector with or without Cannula and with or without Visualization K953377 Tapered Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon… | 1995 |
| * | K935426 | Preperitoneal Distention Balloon SystemSummary page 1…Cannula K962702 Spacemaker® Serial Surgical Balloon Dissector with or without Cannula and with or without Visualization K953377 Tapered Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon System K954174 Duo Balloon System (1and 2) K96… | 1994 |
| * | K946002 | Origin Preperitoneal Dissection Balloon System (PDBS)--ExtraSummary page 1…oon Dissector with or without Cannula and with or without Visualization K953377 Tapered Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon System K954174 Duo Balloon System (1and 2) K964171 VasosView Balloon Dissection System 6. Devi… | 1995 |
| * | K954174 | Duo Balloon System (DBS) 2 [10 and 12 MM Sizes]Summary page 1…r without Visualization K953377 Tapered Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon System K954174 Duo Balloon System (1and 2) K964171 VasosView Balloon Dissection System 6. Device Description The Spacemaker® Surgical Balloon… | 1995 |
| * | K964171 | Vasoview Balloon Dissection SystemSummary page 1…red Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon System K954174 Duo Balloon System (1and 2) K964171 VasosView Balloon Dissection System 6. Device Description The Spacemaker® Surgical Balloon Dissector devices are handheld, manu… | 1997 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K090631 (PAJUNK GmbH Medizintechnologie, 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal and retroperitoneal), or subcutaneous extremity or thoracic space. The indications for use…
Read the full statement (241 words)
The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal and retroperitoneal), or subcutaneous extremity or thoracic space.
The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery; vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall, procedures in the extraperitoneal space involving dissection of tissue layers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys.
Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial layers between the skin and peritoneum, hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating.
The cannula portion of the device is intended to provide access for surgical 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.
https://510kreport.com/device/K973046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973046
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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