510(k) · Cleared
Recalled · 2008Dilating Tip Obturator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 17, 2002 after a 142-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 17, 2002
- Review
- 142 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 7
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK012884 Dilating Tip ObturatorApplied Medical Resources Corp. · 2002
- Descendant · cites it directly · 13 of its ownK032889 Optical SeparatorApplied Medical Resources · 2003
- Descendant · 2 generations on · 10 of its ownK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
- Descendant · 3 generations on · 4 of its ownK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
- Descendant · 4 generations on · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK072674 Kii Trocar SystemApplied Medical Resources Corp. · 2007 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K032889Optical SeparatorApplied Medical Resources · 2003 · cites it directly13descendants
- K060096Modular Trocar SystemApplied Medical Resources Corp. · 2006 · 2 generations on10descendants
- K083638Fixation TrocarsApplied Medical Resources Corp. · 2008 · 3 generations on4descendants
- K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · 4 generations on2descendants
- K072674Kii Trocar SystemApplied Medical Resources Corp. · 2007 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012884 | Dilating Tip Obturator | Applied Medical Resources Corp. | 2002 | — |
| +1 | K032889 | Optical Separator | Applied Medical Resources | 2003 | — |
| +2 | K060096 | Modular Trocar System | Applied Medical Resources Corp. | 2006 | 7 |
| +3 | K083638 | Fixation Trocars | Applied Medical Resources Corp. | 2008 | 1 |
| +4 | K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021 | — |
| +3 | K072674 | Kii Trocar System | Applied Medical Resources Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | — | EndoPath Optiview Optical Surgical Obturator Named without a submission number |
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2008 | Not classified | Z-0023-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0025-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0026-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0027-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0028-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0029-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Jun 25, 2008 | Not classified | Z-0024-2009 | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032889 (Applied Medical Resources, 2003) has gone furthest, with 13 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 Dilating Tip Obturator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
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/K012884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012884: Dilating Tip Obturator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012884
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026