510(k) · Cleared
ClearedMiniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solos Endoscopy, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 6, 1998 as substantially equivalent to K932987 (Birtcher Medical Systems, Inc., 1994) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K926166 (1993). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926166 Coast Video Endoscopic Imaging SystemOptik · 1993
- This deviceK983538 Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic…Solos Endoscopy, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK983527 Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK082735 Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK040949 Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K983527Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999 · cites it directly4descendants
- K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006 · 2 generations on2descendants
- K093785Modular EndoscopeSialo Technology, Ltd. · 2010 · 3 generations on0descendants
- K082735Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009 · 3 generations on0descendants
- K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926166 | Coast Video Endoscopic Imaging System | Optik | 1993 | — |
| 0 (this device) | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing… | Solos Endoscopy, Inc. | 1998 | — |
| +1 | K983527 | Microendoscope, Miniaturized Biopsy Scope | Dofi Technologies, Inc. | 1999 | — |
| +2 | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| +3 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +3 | K082735 | Stone Grasping Basket, Model PD-T1 2115 | Sialo Technology, Ltd. | 2009 | — |
| +2 | K040949 | Viaduct Miniscope and Accessories | Acueity, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932987 | Birtcher Laparoscope and AccessoriesSummary page 1…by Solos Endoscopy, Inc., and no less than 20 other companies with similar devices with very similar characteristics. These devices now under commercial distribution are K932987, K931065 and K926166. Others with very similar characteristics are listed and under commercial distribution by Omega,, Candela La… | 1994 |
| Kept off the family tree | K931065 | FDA’s K931065 is Laparoview Our OCR of the scanned summary read K931065, FDA’s number for Laparoview (Northgate Technologies, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1…Endoscopy, Inc., and no less than 20 other companies with similar devices with very similar characteristics. These devices now under commercial distribution are K932987, K931065 and K926166. Others with very similar characteristics are listed and under commercial distribution by Omega,, Candela Laser and o… | 1994 |
| * | K926166 | Coast Video Endoscopic Imaging SystemSummary page 1…nc., and no less than 20 other companies with similar devices with very similar characteristics. These devices now under commercial distribution are K932987, K931065 and K926166. Others with very similar characteristics are listed and under commercial distribution by Omega,, Candela Laser and other manufac… | 1993 |
| * | K971996 | Medivision ArthroscopSummary page 1…but not limited to; Fujinon, Olympus, Baxter, Stryker, Linvatec, Karl Storz et al. Each markets similar devices. The design of SOLOS ENDOSCOPY made/marketed endoscopes K971996, K926166 is virtually the same as scopes approved for intended use for the purpose of visualization of surgical procedures. Each… | 1997 |
| † | K753535 | DF-0012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983527 | Microendoscope, Miniaturized Biopsy Scope | 1999 | 4 |
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?
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 Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.
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/K983538 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983538: Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983538
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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