# K012884: Dilating Tip Obturator

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Jan 17, 2002 after 142 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EndoPath Optiview Optical Surgical Obturator: named in the summary without a submission number

## Most influential descendants
- K032889: Optical Separator (2003), 13 descendants of its own
- K060096: Modular Trocar System (2006), 10 descendants of its own
- K083638: Fixation Trocars (2008), 4 descendants of its own
- K211577: SoftFix Balloon Trocar (2021), 2 descendants of its own
- K072674: Kii Trocar System (2007), 2 descendants of its own

## Recalls of this device
- Jun 25, 2008 · Not classified · Z-0023-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0025-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0026-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0027-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0028-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0029-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0024-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in

## Indications for use
The Dilating Tip Obturator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Source page: https://510kreport.com/device/K012884
Methodology: https://510kreport.com/methodology