510(k) · Cleared
ClearedDiamond-Flex (R) Graspers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 6, 2011 as substantially equivalent to K930667 (Snowden-Pencer, 1994) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 6, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930667 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- This deviceK110257 Diamond-Flex (R) GraspersCarefusion 2200, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| 0 (this device) | K110257 | Diamond-Flex (R) Graspers | Carefusion 2200, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K930667 | Reusable Laparoscopic InstrumentsSummary page 2…ons Characteristic Reusable Limited EndloFlex: 5000 New Device Laparoscopic Endloscopic Forceps - Instruments - k930667 K(946239 Type of Device Reusable Reusable Reusable Materials Stain… | 1994 |
| * | K946239 | Endoxflex 5000 Our reading of the summary gave K946236, FDA’s number for Profix Conforming Plus Tibial Insert (Smith & Nephew Richards, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Surgical Innovations Limited - EndoFlex 5000 Endoscopic Forceps”. | 1995 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K930667.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110257: Diamond-Flex (R) Graspers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110257
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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