# K971255: Imagyn Expandable Laparoscopic Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Apr 21, 1997 after 17 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Imagyn MicroLap Introducer: named in the summary without a submission number
- (no number) Innerdyne, Inc. Step Trocar Expandable Port: named in the summary without a submission number

## Indications for use
The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures.

Source page: https://510kreport.com/device/K971255
Methodology: https://510kreport.com/methodology