# K013165: Usa Series Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Circon Acmi
- Decided: Jan 18, 2002 after 119 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955845 (1996). 5 ancestors in all.
117 later devices descend from it; 3 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991718: Operating Laparoscope, 10-5 MM, Angeled, Operating Laparoscope 12-7MM, Angled, Operating Laparoscope, 10-5,,. Oblique, D, Richard Wolf Medical Instruments Corp. (1999) Summary page 1.
- K982149: Smith & Nephew Dyonics Microlaparoscope, Smith & Nephew, Inc. (1998) Summary page 1.
- K972504: MVM 3.3 MM Microendoscope, KARL STORZ Endoscopy-America, Inc. (1997) Summary page 1.
- K955845: LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens, Surgical Image Laboratories, Inc. (1996) Summary page 1.
- K001594: 3.5 MM Laparoscope (LG100, LG103), Surgical Image Laboratories, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System (2014), 76 descendants of its own

## Indications for use
CIRCON's USA Series™ Laparoscopes are intended for use by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures. These include, but are not limited to, laparoscopic procedures used in general surgical procedures, cholecystectomy, colon resection or therapeutic thoracoscopy.

Source page: https://510kreport.com/device/K013165
Methodology: https://510kreport.com/methodology