510(k) · Cleared
ClearedModular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 25, 1999 as substantially equivalent to K931340 (Baxter Healthcare Corp, 1993) after a 17-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Jun 25, 1999
- Review
- 17 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931340 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931340 Grasp Forceps/Scissors/Needle Holder/DissectorBaxter Healthcare Corp · 1993
- This deviceK991928 Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders &…Allegiance Healthcare Corp. · 1999
- Descendant · cites it directly · 1 of its ownK100109 Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010
- Descendant · cites it directly · 1 of its ownK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK120403 Spider Flexible Blunt Dissector and Band PasserTransenterix, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK101193 PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010
Most influential descendants
Showing 4 of 4 · See all- K100109Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010 · cites it directly1descendant
- K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008 · cites it directly1descendant
- K120403Spider Flexible Blunt Dissector and Band PasserTransenterix, Inc. · 2012 · 2 generations on0descendants
- K101193PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931340 | Grasp Forceps/Scissors/Needle Holder/Dissector | Baxter Healthcare Corp | 1993 | — |
| 0 (this device) | K991928 | Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors | Allegiance Healthcare Corp. | 1999 | — |
| +1 | K100109 | Logiflex Laparoscopic Band Positioning Device | Surgical Innovations Plc | 2010 | — |
| +1 | K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | 2008 | — |
| +2 | K120403 | Spider Flexible Blunt Dissector and Band Passer | Transenterix, Inc. | 2012 | — |
| +2 | K101193 | PMC Laparoscopic Instruments | Pmc Medical GmbH | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K931340 | Grasp Forceps/Scissors/Needle Holder/DissectorSummary page 1…Y AND EFFECTIVENESS Manufacturer: Regulatory Affairs Contact Telephone: Date Summary Prepared: Product Trade Name: Common Name: Classification: Predicate Device: (K931340) Description: Attachment G Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 6008… | 1993 |
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?
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?
Used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).
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/K991928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991928: Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991928
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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