510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Stryker Strykeflow Suction Irrigator (Modification)

K954726510(k) TraditionalCleared Nov 29, 1995118-day reviewClass II21 CFR 880.6740Recalls 22

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Endoscopy · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Cleared on Nov 29, 1995 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 22 times.

Decided
Nov 29, 1995
Review
118 days
Class
Class II
Product code
GCX
Recalls
22
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2004: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2005: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954726 Stryker Strykeflow Suction Irrigator (Modification)Stryker Endoscopy · 1995
  2. Descendant · cites it directly · 5 of its ownK963765 Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997 · Recalled
  3. Descendant · cites it directly · 4 of its ownK042454 Stryker Cassette PumpStryker Endoscopy · 2004 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK122619 Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012
  5. Descendant · 3 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
  6. Descendant · 4 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1997: 12004: 12005: 12010: 12011: 12012: 12013: 12018: 12019: 12020: 12026: 1
1997high 1 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 11 · See all
  • K963765Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997 · cites it directly5descendants
  • K042454Stryker Cassette PumpStryker Endoscopy · 2004 · cites it directly4descendants
  • K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012 · 2 generations on3descendants
  • K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 3 generations on2descendants
  • K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954726Stryker Strykeflow Suction Irrigator (Modification)Stryker Endoscopy1995—
+1K963765Stryker Strykeflow Electrocautery ProbesStryker Endoscopy19971
+1K042454Stryker Cassette PumpStryker Endoscopy20045
+2K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical2012—
+3K180735Endomat SelectKarl Storz SE & CO. KG2018—
+4K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200410
200510
201010
201110
201210
201310
201810
201910
202010
202610
FIG. 1 — Lineage of K954726, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963765Stryker Strykeflow Electrocautery ProbesStryker Endoscopy19975
K042454Stryker Cassette PumpStryker Endoscopy20044

Has anything in its family been recalled? (0 Class I)

Recalls of this device

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

The 5 latest of 22 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963765 (Stryker Endoscopy, 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All GCX devices

GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCX

FDA has decided no GCX device since 2007.

Median 510(k) review, days · GCX

Too few GCX 510(k)s in any year since 2007 to give a median.

Recalls per year · GCX

1in 2024

2013: 12017: 12023: 32024: 12026 (partial year): 3
2007high 3 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GCX

274in 2025

2007: 242008: 442009: 402010: 512011: 672012: 2422013: 472014: 322015: 522016: 992017: 452018: 502019: 652020: 652021: 652022: 722023: 592024: 652025: 274
2007high 274 (2025) · low 24 (2007)2025

MAUDE reports naming product code GCX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—024
20080—044
20090—040
20100—051
20110—067
20120—0242
20130—147
20140—032
20150—052
20160—099
20170—145
20180—050
20190—065
20200—065
20210—065
20220—072
20230—359
20240—165
20250—0274
20260—3—

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Recent decisions in GCX

The GCX category page

  • K042454Stryker Cassette PumpStryker Endoscopy · 20045 recalls
  • K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
  • K972074Suction InstrumentationWalter Lorenz Surgical, Inc. · 1997
  • K971022Chase SuckerChase Medical, Inc. · 19971 recall
  • K964127Medi-Vac Flexi-Clear Suction HandleAllegiance Healthcare Corp. · 1996

https://510kreport.com/device/K954726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954726: Stryker Strykeflow Suction Irrigator (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954726

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026