# K063788: Reprocessed Endoscopic Trocars and Cannulas

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Oct 15, 2007 after 298 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990028 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041795: Modification to Optical Separator System, Applied Medical Resources Corp. (2004) Summary page 1.
- K032889: Optical Separator, Applied Medical Resources (2003) Summary page 1.
- K012884: Dilating Tip Obturator, Applied Medical Resources Corp. (2002) Summary page 1.
- K012968: Applied Access Seal, Applied Medical Resources Corp. (2001) Summary page 1.

## Recalls of this device
- Jun 1, 2015 · Class II · Z-1836-2015: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
- Jun 1, 2015 · Class II · Z-1835-2015: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
- Jun 1, 2015 · Class II · Z-1834-2015: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

## Indications for use
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Source page: https://510kreport.com/device/K063788
Methodology: https://510kreport.com/methodology