510(k) Report

510(k) · Cleared

Recalled · 2010

Stryker Femoral Canal Sponge & Acetabulum Sponge

K955599510(k) TraditionalCleared Feb 22, 199676-day reviewClass I21 CFR 878.4450Recalls 5

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

Stryker Corp. · GDY Gauze/Sponge, Internal, X-Ray Detectable

Cleared on Feb 22, 1996 after a 76-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 5 times.

Decided
Feb 22, 1996
Review
76 days
Class
Class I
Product code
GDY
Recalls
5
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K955599Source: FDA 510(k) database · 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 25, 2010Not classifiedZ-1104-2010OtherThe firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
Jan 25, 2010Not classifiedZ-1105-2010OtherThe firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
Jan 25, 2010Not classifiedZ-1108-2010OtherThe firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
Jan 25, 2010Not classifiedZ-1107-2010OtherThe firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
Jan 25, 2010Not classifiedZ-1106-2010OtherThe firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GDY devices

GDY Gauze/Sponge, Internal, X-Ray Detectable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDY

FDA has decided no GDY device since 2007.

Median 510(k) review, days · GDY

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

Recalls per year · GDY

1in 2022

2008: 12010: 72012: 22015: 22017: 12018: 12019: 12022: 12026 (partial year): 1, 1 Class I
2007high 7 (2010) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GDY

112in 2025

2007: 152008: 252009: 962010: 442011: 382012: 802013: 402014: 652015: 1222016: 2912017: 2522018: 2502019: 1772020: 1162021: 1342022: 2262023: 982024: 1142025: 112
2007high 291 (2016) · low 15 (2007)2025

MAUDE reports naming product code GDY, 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—015
20080—125
20090—096
20100—744
20110—038
20120—280
20130—040
20140—065
20150—2122
20160—0291
20170—1252
20180—1250
20190—1177
20200—0116
20210—0134
20220—1226
20230—098
20240—0114
20250—0112
20260—1 (1)—

More from Stryker Corp.

156 FDA decisions under this applicant name. See the company

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  • K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
  • K182359HipCheckStryker Corp. · 2018
  • P050044/S033Vitagel RT3 Sutgical HemostatStryker Corp. · 2017
  • P050044/S032Vitagel RT3 Surgical HemostatStryker Corp. · 2015

Recent decisions in GDY

The GDY category page

  • K972634Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K960236CPR Lap SpongesCustom Pack Reliability · 1996
  • K955322Protec X-Ray Detectable Gauze SpongeDerivados DE Gasa, S.A. DE C.V. · 1995
  • K953830KensorbKentron Health Care, Inc. · 1995
  • K953059Kittner DissectorMedical Perspectives Corp. · 1995

https://510kreport.com/device/K955599 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955599: Stryker Femoral Canal Sponge & Acetabulum Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955599

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