# K960637: 5MM Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Origin Medsystems, Inc.
- Decided: Jun 14, 1996 after 121 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
No predicates in its family tree.
68 later devices descend from it; 4 cite it directly.
5 of 69 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) ORIGIN Small Diameter Endoscope: named in the summary without a submission number

## Most influential descendants
- K030512: Guidant Vasoview Endoscopic Vessel Harvesting System (2003), 62 descendants of its own
- K060723: 40 L High Flow Insufflator F113 (2006), 45 descendants of its own
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own

## Indications for use
The Smm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a Smm diameter endoscope as their visualization component.

Source page: https://510kreport.com/device/K960637
Methodology: https://510kreport.com/methodology