510(k) Report

510(k) · Cleared

Cleared

Surgicade Gauze Sponge

K962972510(k) TraditionalCleared Oct 11, 199672-day reviewClass U

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

Accunex Canada,Inc. · EFQ Gauze/Sponge, Internal

Cleared on Oct 11, 1996 as substantially equivalent to K922055 (Team Mfg., Inc., 1992) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1992.

Decided
Oct 11, 1996
Review
72 days
Class
Class U
Product code
EFQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K922055 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK922055 · Sterile and Non-Sterile Gauze Sponges · Team Mfg., Inc. · 199219901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K922055 · Sterile and Non-Sterile Gauze Sponges · Team Mfg., Inc. · 19920
  1. Root · 1 generation backK922055 Sterile and Non-Sterile Gauze SpongesTeam Mfg., Inc. · 1992
  2. This deviceK962972 Surgicade Gauze SpongeAccunex Canada,Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922055Sterile and Non-Sterile Gauze SpongesTeam Mfg., Inc.1992—
0 (this device)K962972Surgicade Gauze SpongeAccunex Canada,Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K962972, 1992–1996Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EFQ? 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
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K922055Sterile and Non-Sterile Gauze Sponges
Summary page 1
…: Surgicade ™ Non-Sterile Gauze Sponges Common Name: Wound Dressing Classification Name: Gauze Sponge i. PREDICATE DEVICES Non-Sterile Gauze Sponges (Team Mfg., Inc.); K922055. Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products); K942070 IV. DEVICE DESCRIPTION Surgicade™ Non-Sterile Gauze Sponge…
Team Mfg., Inc.1992—
*K942070Lorrex Cover Sponges STERILE2'S and Non-Sterile
Summary page 1
…lassification Name: Gauze Sponge i. PREDICATE DEVICES Non-Sterile Gauze Sponges (Team Mfg., Inc.); K922055. Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products); K942070 IV. DEVICE DESCRIPTION Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type Vil gauze, available in thicknesses of 8 p…
Lorrex Health Products1994—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All EFQ devices

EFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFQ

FDA has decided no EFQ device since 2007.

Median 510(k) review, days · EFQ

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

Recalls per year · EFQ

3so far in 2026, the most since 2007

2020: 12022: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · EFQ

51in 2025

2007: 42009: 42010: 92011: 62012: 92013: 82014: 112015: 272016: 532017: 82018: 72019: 52020: 82021: 62022: 62023: 102024: 82025: 51
2007high 53 (2016) · low 0 (2008)2025

MAUDE reports naming product code EFQ, 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—04
20080—00
20090—04
20100—09
20110—06
20120—09
20130—08
20140—011
20150—027
20160—053
20170—08
20180—07
20190—05
20200—18
20210—06
20220—16
20230—010
20240—08
20250—051
20260—3—

What is it indicated for?

Control bleeding, absorb body fluids, and protect wounds from contamination.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in EFQ

The EFQ category page

  • K991757Non-Absorbable Gauze for External Use, Sterile and Non SterileFurlong Industries · 1999
  • K991215Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SSymtex Healthcare Corp. · 1999
  • K990974Vitop DressingWonder & Bioenergy Hi-Tech America, Inc. · 1999
  • K990584Gauze Sponges: Laparotomy Sponge, X-Ray DetectableBroadline Medical Industries · 1999
  • K984187Crosstex Non-Woven SpongesCrosstex Intl. · 19992 recalls

https://510kreport.com/device/K962972 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962972: Surgicade Gauze Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962972

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026