# K041806: Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Aug 3, 2004 after 28 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010673 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964345: Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, Undyed, ETHICON, Inc. (1996) Summary page 2.
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 2.
- (no number) ETHIBOND sutures: named in the summary without a submission number

## Most influential descendants
- K042233: Passing Needle with Ethibond, Panacryl or Orthocord Suture (2004), 0 descendants of its own

## Indications for use
Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction. Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Source page: https://510kreport.com/device/K041806
Methodology: https://510kreport.com/methodology