# K954726: Stryker Strykeflow Suction Irrigator (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Nov 29, 1995 after 118 days
- Product code: GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 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
- K963765: Stryker Strykeflow Electrocautery Probes (1997), 5 descendants of its own
- K042454: Stryker Cassette Pump (2004), 4 descendants of its own
- K122619: Epix Irrigation Pump, Epix Suction Irrigation Tubing Set (2012), 3 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own
- K201355: Endomat Select, IBS Shaver Software, License (2020), 1 descendant of its own

## Recalls of this device
- Jun 18, 2025 · Class II · Z-2171-2025: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Nov 17, 2017 · Class II · Z-0835-2018: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- Mar 27, 2013 · Class II · Z-1225-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1220-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1235-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1224-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1226-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1223-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1233-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1229-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1237-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1219-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1218-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1232-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1234-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1231-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1228-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1230-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1222-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1227-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1236-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
- Mar 27, 2013 · Class II · Z-1221-2013: The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.

Source page: https://510kreport.com/device/K954726
Methodology: https://510kreport.com/methodology