# K955650: Olympus SD Series Snares

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 29, 1996 after 108 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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) Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares: named in the summary without a submission number
- (no number) Olympus SD-14/15 sterile disposable snares: named in the summary without a submission number

## Most influential descendants
- K131700: Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy Snares (2013), 15 descendants of its own
- K133987: Captivator II,Single-Use Polypectomy Snares (2014), 10 descendants of its own
- K172729: Polypectomy Snare (2018), 5 descendants of its own
- K160637: Rotatable Snares (2016), 4 descendants of its own
- K172758: Rotatable Snares, Non-Rotatable Snares (2018), 3 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0987-2021: 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-0990-2021: 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-0988-2021: 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-0989-2021: 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.
- May 3, 2010 · Not classified · Z-2236-2010: An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.

## Indications for use
The SD series of snares and the predicated shares are all designed to endoscopically resect tissue from within the Gl tract.

Source page: https://510kreport.com/device/K955650
Methodology: https://510kreport.com/methodology