# K062497: Reprocessed Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Jan 31, 2007 after 159 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940232 (1994). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.
- K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars, Vanguard Medical Concepts, Inc. (2005) Summary page 1.
- K043594: Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories, Vanguard Medical Concepts, Inc. (2005) Summary page 1.

## Most influential descendants
- K132629: Reprocessed Dilating Tip Trocars (2013), 0 descendants of its own
- K100080: Reprocessed Trocars, Model B5LT and CB5LT (2010), 0 descendants of its own

## Recalls of this device
- Jun 19, 2018 · Class II · Z-0498-2019: Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities i
- Nov 11, 2016 · Class II · Z-0765-2017: An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

## 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/K062497
Methodology: https://510kreport.com/methodology