510(k) · Cleared
ClearedMicrofrance Laparoscopic Manual Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 22, 2008 as substantially equivalent to K012660 (Gimmi GmbH, 2001) and 2 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- May 22, 2008
- Review
- 112 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931340 (1993). 11 ancestors in all, the oldest K792365 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931340 Grasp Forceps/Scissors/Needle Holder/DissectorBaxter Healthcare Corp · 1993
- 1 generation backK991928 Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders &…Allegiance Healthcare Corp. · 1999
- This deviceK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK101193 PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010
Most influential descendants
Showing 1 of 1 · See all- K101193PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931340 | Grasp Forceps/Scissors/Needle Holder/Dissector | Baxter Healthcare Corp | 1993 | — |
| −1 | K991928 | Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors | Allegiance Healthcare Corp. | 1999 | — |
| 0 (this device) | K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | 2008 | — |
| +1 | K101193 | PMC Laparoscopic Instruments | Pmc Medical GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012660 | Gimmi'alpha' Endoscopes & AccessoriesSummary page 1…ance Laparoscopic Instruments are equivalent to Geister Medizintechnik GMBH GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories - K012660, Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors - K991928, MicroFrance Electrosurgical Instrum… | 2001 |
| * | K991928 | Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & DissectorsSummary page 1…A Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories - K012660, Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors - K991928, MicroFrance Electrosurgical Instruments - K993655, and MicroFrance Laparoscopic Manual Surgical Instruments for gynecolog… | 1999 |
| * | K993655 | Micro-France Electrosurgical Instruments, VariousSummary page 1…opic Accessories - K012660, Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors - K991928, MicroFrance Electrosurgical Instruments - K993655, and MicroFrance Laparoscopic Manual Surgical Instruments for gynecological use. Device Description The subject in… | 1999 |
| * | — | MicroFrance Laparoscopic Manual Surgical Instruments for gynecological use Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101193 | PMC Laparoscopic Instruments | 2010 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K101193 (Pmc Medical GmbH, 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012660.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080257: Microfrance Laparoscopic Manual Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080257
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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