# K962777: Amr Mini-Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Aug 6, 1997 after 385 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) MICROLAP™ 2mm LAPAROSCOPE and INTRODUCER: named in the summary without a submission number

## Indications for use
The AMR Mini-Laparoscope is indicated for visualization and accessing the abdomen during laparoscopic procedures such as (but not limited to): Unexplained pelvic pain Infertility Work-up Tubal sterilization Diagnosis and/or treatment of ectopic pregnancy Evaluation, diagnosis and/or treatment of pelvic tumors, including myomata (less than 16 weeks gestational size.) Evaluation of congenital anomalies of the pelvic organs Retrieval of foreign bodies Determination of the presence and extent of pelvic endometriosis Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage) Access to abdomen for surgical procedures such as LAVH Visualization, diagnosis and/or treatment of perforate abdominal (pelvic) organs.

Source page: https://510kreport.com/device/K962777
Methodology: https://510kreport.com/methodology