# K103726: Jarit Take-Apart Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Feb 8, 2012 after 413 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932832 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932456: Jarit Surgical Instruments, J. Jamner Surgical Instruments, Inc. (1994) Summary page 2.
- K010752: Aesculap's Modular Endoscopic Instruments for Gynecology, Aesculap, Inc. (2001) Summary page 2.
- K103282: Laparoscopic Dissector, Applied Medical Resources Corp. (2010) Summary page 2.
- K962119: RE-New Laparoscopic Instruments, Microline Pentax, Inc. (1996) Summary page 2.
- K043013: Miltex Laparoscopic Instruments, Miltex, Inc. (2005) Summary page 2.

## Recalls of this device
- May 23, 2012 · Class II · Z-2028-2012: The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.

## Indications for use
Integra TM Jarit® Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecologic surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. For those instruments with electrosurgical capability, current can be used for coagulation and/or culling as determined necessary and appropriate by the surgeon.

Source page: https://510kreport.com/device/K103726
Methodology: https://510kreport.com/methodology