FDA product code EFQ: Gauze/Sponge, Internal
EFQ is the FDA product code for gauze/sponge, internal. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 271 510(k) submissions under EFQ, from 139 different applicants. The average 510(k) review took 58 days (median 39). FDA has posted 13 recalls for EFQ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gauze/Sponge, Internal |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every EFQ clearance
Top EFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mcneil Healthcare, Inc. | 14 | 1994-02-03 |
| Ormed Mfg., Inc. | 14 | 1988-07-18 |
| American Medical Disposable, Inc. | 13 | 1980-11-12 |
| Ritmed, Inc. | 10 | 1983-06-08 |
| Certified Safety Mfg., Inc. | 8 | 1996-11-25 |
134 more applicants have EFQ clearances. See the full list in Caduvo.
Most recent EFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991757 | Furlong Industries | NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE | 1999-08-12 | 80 |
| K991215 | Symtex Healthcare Corp. | SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S | 1999-06-11 | 63 |
| K990974 | Wonder & Bioenergy Hi-Tech America, Inc. | VITOP DRESSING | 1999-06-09 | 78 |
| K990584 | Broadline Medical Industries | GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE | 1999-04-23 | 59 |
| K984187 | Crosstex Intl. | CROSSTEX NON-WOVEN SPONGES | 1999-02-18 | 87 |
Recalls for EFQ devices
13 product recalls in 7 recall events; 6 initiated in the last five years and 4 still open. Most recent: 2026-05-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 3 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code EFQ?
EFQ is the FDA product code for gauze/sponge, internal. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is EFQ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code EFQ?
Across 271 cleared submissions the average was 58 days from receipt to decision (median 39).
Which companies have the most EFQ clearances?
Mcneil Healthcare, Inc. (14); Ormed Mfg., Inc. (14); American Medical Disposable, Inc. (13); Ritmed, Inc. (10); Certified Safety Mfg., Inc. (8).
Have EFQ devices been recalled?
Yes: 13 product recalls across 7 recall events; the most recent began 2026-05-08.
Next steps
- Run an FDA pathway report with predicate devices for product code EFQ
- Run a recall and safety report across every EFQ manufacturer
- Watch product code EFQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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