# K982149: Smith & Nephew Dyonics Microlaparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 10, 1998 after 84 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.
118 later devices descend from it; 1 cites it directly.
0 of 119 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) Richard Wolf Medical 2.0mm mini laparoscope: named in the summary without a submission number

## Most influential descendants
- K013165: Usa Series Laparoscopes (2002), 117 descendants of its own
- K091515: Spy Scope Intra-Operative Operating System (2009), 106 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 descendants of its own
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own

## Indications for use
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures. For use in gynecological laparoscopy the following specific indications apply: Unexplained pelvic pain (acute, chronic) Infertility work-up Tubal sterilization Diagnosis and/or treatment of ectopic pregnancy Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (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 perforated abdominal (pelvic) organs

Source page: https://510kreport.com/device/K982149
Methodology: https://510kreport.com/methodology