# K110257: Diamond-Flex (R) Graspers

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200, Inc.
- Decided: May 6, 2011 after 98 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930667 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930667: Reusable Laparoscopic Instruments, Snowden-Pencer (1994) Summary page 2.
- K946239: Endoxflex 5000, Michael A Clark (1995). 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”. Summary page 2.

## Indications for use
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.

Source page: https://510kreport.com/device/K110257
Methodology: https://510kreport.com/methodology