# K902735: SD Snares

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Aug 2, 1990 after 42 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081580: Beamer Argon Snare Probe (2008), 1 descendant of its own
- K091355: Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998 (2009), 0 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0984-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0985-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0986-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1071-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1070-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Source page: https://510kreport.com/device/K902735
Methodology: https://510kreport.com/methodology