510(k) · Cleared
ClearedFastclamp Endoscopic Clamping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Innovations Group Plc · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 7, 2010 as substantially equivalent to K092684 (Cardinal Health, Inc., 2010) and 1 other predicate after a 202-day review. Its family tree reaches back 4 generations to 1995. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 7, 2010
- Review
- 202 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945572 (1995). 10 ancestors in all, the oldest K933008 (1994). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 3 generations backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- 2 generations backK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- 1 generation backK070509 Fisso Holding SystemBaitella AG · 2007
- This deviceK100442 Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010
Class I recalls in this family
- K092684 Laparoscopic Retractorsdirect predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| −2 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| −1 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| 0 (this device) | K100442 | Fastclamp Endoscopic Clamping System | Surgical Innovations Group Plc | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2010 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K092684 | Laparoscopic RetractorsSummary page 1…roscope, General and Plastic Surgery (21 CFR 876.1500, Product Code GCJ) Equivalent to: Laparoscopic Retractors- Cardinal Health, Inc. (K(092684) FISSO Holding System - Baitella AG (1(070509). Mediflex Flex Arm Systems - Medifle… | 2010 |
| * | K070509 | Fisso Holding SystemSummary page 1…76.1500, Product Code GCJ) Equivalent to: Laparoscopic Retractors- Cardinal Health, Inc. (K(092684) FISSO Holding System - Baitella AG (1(070509). Mediflex Flex Arm Systems - Mediflex surgical products (pre-amendments device).… | 2007 |
| * | — | Mediflex Flex Arm Systems - Mediflex surgical products Named without a submission number | |
| * | — | Thompson Retractor - Thompson Surgical Instruments, Inc. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092684Laparoscopic RetractorsCardinal Health, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K092684.
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?
Use in laparoscopic procedures for the surgeon to clamp endloscopic instruments in a fixed position for a period of time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100442: Fastclamp Endoscopic Clamping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100442
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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