# K963646: Stryker Strykeflow Suction Irrigator Gravity Flow

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Apr 16, 1997 after 216 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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) Nezhat-Dorsey device: named in the summary without a submission number
- (no number) Stryker Strykeflow Suction Irrigator: named in the summary without a submission number
- (no number) equivalent gravity flow and bulb/syringe devices: named in the summary without a submission number

## Most influential descendants
- K041967: Genicon Suction Irrigation System (2004), 9 descendants of its own
- K103509: Unimax Suction Irrigation Set (2011), 8 descendants of its own
- K192643: Dannik Laparoscopic Suction Irrigation System (2019), 2 descendants of its own
- K141592: Unimicro Suction Irriation Tubing Set (2014), 2 descendants of its own
- K991323: Smith & Nephew Subcutaneous Illuminator (1999), 2 descendants of its own

## Recalls of this device
- Jun 8, 2026 · Class II · Z-2865-2026: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Jun 8, 2026 · Class II · Z-2866-2026: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

## Indications for use
The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.

Source page: https://510kreport.com/device/K963646
Methodology: https://510kreport.com/methodology