Product code EFQ: 510(k) clearances and predicates
Product code EFQ covers NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE. FDA lists 271 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
271 clearances on file under product code EFQ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest EFQ clearances in the FDA index, with applicant and decision date:
- K991757, NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE, applicant Furlong Industries, decided 1999-08-12. FDA record
- K991215, SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S, applicant Symtex Healthcare Corp., decided 1999-06-11. FDA record
- K990974, VITOP DRESSING, applicant Wonder & Bioenergy Hi-Tech America, Inc., decided 1999-06-09. FDA record
- K990584, GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE, applicant Broadline Medical Industries, decided 1999-04-23. FDA record
- K984187, CROSSTEX NON-WOVEN SPONGES, applicant Crosstex Intl., decided 1999-02-18. FDA record
- K983016, GAUZE, SPONGES, CAT # 11-003, applicant Vitalcare Group, Inc., decided 1999-02-12. FDA record
- K983348, DYNAREX TRACHEOSTOMY SPONGE, applicant Dynarex Corp., decided 1998-12-11. FDA record
- K983450, STARRYSHINE GAUZE SPONGE, applicant T.C. Dental Products, Inc., decided 1998-11-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S, VITOP DRESSING. Watch new EFQ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code EFQ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EFQ clearances include NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE.
How many 510(k) clearances use product code EFQ?
271 at the time this page was generated, from openFDA records.
How do I find a predicate device under EFQ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new EFQ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for EFQ, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free EFQ brief
Tell us where to send it. No card required.
You are on the list.
We will email your free EFQ brief shortly. EFQ is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.