510(k) · Cleared
ClearedPMC Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmc Medical GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 18, 2010 as substantially equivalent to K012660 (Gimmi GmbH, 2001) and 1 other predicate after a 173-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Oct 18, 2010
- Review
- 173 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931340 (1993). 12 ancestors in all, the oldest K792365 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK931340 Grasp Forceps/Scissors/Needle Holder/DissectorBaxter Healthcare Corp · 1993
- 2 generations backK991928 Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders &…Allegiance Healthcare Corp. · 1999
- 1 generation backK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
- This deviceK101193 PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931340 | Grasp Forceps/Scissors/Needle Holder/Dissector | Baxter Healthcare Corp | 1993 | — |
| −2 | K991928 | Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors | Allegiance Healthcare Corp. | 1999 | — |
| −1 | K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | 2008 | — |
| 0 (this device) | 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 |
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? (2)
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…pe, general & plastic surgery, Endoscope and accessories, Review Panel General & Plastic Surgery (21 CFR 876.1500, GCJ) »> Predicate Device Information: 5 10(k)-Number: K012660, GIMMI ALPHAV Instruments & Accessories Firm: GIMMI GMBH 5 10(k)-Number: K080257, MicroFrance Laparoscopic Manual Surgical Instr… | 2001 |
| * | K080257 | Microfrance Laparoscopic Manual Surgical InstrumentsSummary page 1…lastic Surgery (21 CFR 876.1500, GCJ) »> Predicate Device Information: 5 10(k)-Number: K012660, GIMMI ALPHAV Instruments & Accessories Firm: GIMMI GMBH 5 10(k)-Number: K080257, MicroFrance Laparoscopic Manual Surgical Instruments Firm: MEDTRONIC XOMED, INC.… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 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. 2010, 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?
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101193: PMC Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101193
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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