510(k) · Cleared
ClearedProtec Sterile Gauze Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derivadas Degasa S.A. DE C.V. · EFQ Gauze/Sponge, Internal
Cleared on Jul 29, 1996 as substantially equivalent to K895086 (Keilei Intl., Inc., 1989) after an 82-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 29, 1996
- Review
- 82 days
- Class
- Class U
- Product code
- EFQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895086 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895086 Gauze SpongeKeilei Intl., Inc. · 1989
- This deviceK961773 Protec Sterile Gauze SpongeDerivadas Degasa S.A. DE C.V. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895086 | Gauze Sponge | Keilei Intl., Inc. | 1989 | — |
| 0 (this device) | K961773 | Protec Sterile Gauze Sponge | Derivadas Degasa S.A. DE C.V. | 1996 | — |
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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895086 | Gauze SpongeSummary page 1…t Person: Patrick J. Lamb Date of Summary: May 6, 1996 Trade Name: Protec Sterile Gauze Sponge Classification Name: Gauze Sponge Predicate Device: | Keilel International K895086 Device Description/ DeGasa USP Gauze are sterile gauze sponges that are made with 100 % cotton, and are in the form of plain wov… | 1989 |
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?
- Its one ancestor has no 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?
DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961773 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961773: Protec Sterile Gauze Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961773
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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