# K965055: Imagyn Microlap and Micro Lap-Gold Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Mar 6, 1997 after 78 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.
19 later devices descend from it; 2 cite it directly.
0 of 20 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) Imagyn MicroLap Laparoscope: named in the summary without a submission number
- (no number) Medical Dynamics Optical Catheter: named in the summary without a submission number
- (no number) Optimed Technologies Model F18-200 Laparoscope: named in the summary without a submission number
- (no number) Origin Medsystems, Inc. Small Diameter Endoscope: named in the summary without a submission number
- (no number) Galileo Endoscope: named in the summary without a submission number

## Most influential descendants
- K982623: Aesculap Needlescopic Instrument System (1998), 17 descendants of its own
- K123102: Sovereign Mini (2013), 13 descendants of its own
- K173919: HX Device (2018), 8 descendants of its own
- K203603: Monopolar Hook (2021), 3 descendants of its own
- K143299: Percuvance (R) Percutaneous Surgical System (2015), 2 descendants of its own

## Indications for use
The MicroLap™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnaostic and surgical procedures.

Source page: https://510kreport.com/device/K965055
Methodology: https://510kreport.com/methodology