# K012968: Applied Access Seal

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Dec 3, 2001 after 90 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 K932995 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932995: Surgical Trocar and Cannula, Applied Medical Resources (1993) Summary page 1.

## Most influential descendants
- K111002: Reprocessed Endoscopic Trocars (2011), 0 descendants of its own
- K063788: Reprocessed Endoscopic Trocars and Cannulas (2007), 0 descendants of its own

## Indications for use
The Applied Access Seal is a sterile single use device, indicated for use in conjunction with Applied’s currently marketed Trocar products where a port of entry is desired for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.

Source page: https://510kreport.com/device/K012968
Methodology: https://510kreport.com/methodology