510(k) · Cleared
ClearedSymtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symtex Healthcare Corp. · EFQ Gauze/Sponge, Internal
Cleared on Jun 11, 1999 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 11, 1999
- Review
- 63 days
- Class
- Class U
- Product code
- EFQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All EFQ devicesEFQ 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFQ
51in 2025
MAUDE reports naming product code EFQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 53 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 1 | 8 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
THIS PRODUCT IS INTENDED TO BE USED BY:
SURGEONS
NURSES
LAB TECHNICIANS
I.V. TEAMS
FOR THE FOLLOWING PROCEDURES:
WOUND DRESSING
DEBRIDEMENT
CLEANING
PREPPING AND SCRUBBING
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991215 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991215: Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991215
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026