510(k) · Cleared
ClearedMicroendoscope, Miniaturized Biopsy Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dofi Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 19, 1999 as substantially equivalent to K983538 (Solos Endoscopy, Inc., 1998) and 2 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Jan 19, 1999
- Review
- 103 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K926166 (1993). 6 ancestors in all, the oldest K910732 (1991). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926166 Coast Video Endoscopic Imaging SystemOptik · 1993
- 1 generation backK983538 Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic…Solos Endoscopy, Inc. · 1998
- This deviceK983527 Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK082735 Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK040949 Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006 · cites it directly2descendants
- K093785Modular EndoscopeSialo Technology, Ltd. · 2010 · 2 generations on0descendants
- K082735Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009 · 2 generations on0descendants
- K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926166 | Coast Video Endoscopic Imaging System | Optik | 1993 | — |
| −1 | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing… | Solos Endoscopy, Inc. | 1998 | — |
| 0 (this device) | K983527 | Microendoscope, Miniaturized Biopsy Scope | Dofi Technologies, Inc. | 1999 | — |
| +1 | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| +2 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +2 | K082735 | Stone Grasping Basket, Model PD-T1 2115 | Sialo Technology, Ltd. | 2009 | — |
| +1 | K040949 | Viaduct Miniscope and Accessories | Acueity, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability Cleared while this submission was under review Summary page 1…Summary DOFI Communications confirms that the Miniature Endo/Laparoscope listed in this 510(k) is IDENTICAL in every way to the device marketed by Solos Endoscopy under K983538and therefore this device is Substantially Equivalent, in terms of physical characteristics, to the legally marketed devices alrea… | 1998 |
| Kept off the family tree | K936857 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…bishi Inc. America, and no less than 20 other companies with similar devices with very similar characteristics. These other devices now under commercial distribution are K936857, and K935834. Others with very similar characteristics are listed and under commercial distribution by Omega under K91109C and Ca… | |
| * | K935834 | Tas-211/2.3 Ultrathin Flexible EndoscopeSummary page 1…erica, and no less than 20 other companies with similar devices with very similar characteristics. These other devices now under commercial distribution are K936857, and K935834. Others with very similar characteristics are listed and under commercial distribution by Omega under K91109C and Candela Laser u… | 1994 |
| Kept off the family tree | K911090 | FDA’s K911090 is Omega Angioscopes (Omegascopes) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1991 |
| * | K910732 | Candela Mini-UB EndoscopeSummary page 1…stribution are K936857, and K935834. Others with very similar characteristics are listed and under commercial distribution by Omega under K91109C and Candela Laser under K910732. Other manufacturer’s, such as, but not limited to; Fujinon, Olympus, Baxter, Stryker, Linvatec, Karl Storz et al, market similar… | 1991 |
What descends from it? (4)
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 6 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K051073 (Millennium Devices, Inc., 2006) has gone furthest, with 2 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 Indications for this device use is for medical practitioner needing visualization of soft tissue, 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/K983527 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983527: Microendoscope, Miniaturized Biopsy Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983527
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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