FDA product code GEC: Brush, Scrub, Operating-Room
GEC is the FDA product code for brush, scrub, operating-room. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 37 510(k) submissions under GEC, from 25 different applicants. The average 510(k) review took 38 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Brush, Scrub, Operating-Room |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GEC clearance
Top GEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexide, Inc. | 10 | 1981-05-05 |
| Absorbent Cotton Co., Inc. | 2 | 1988-02-18 |
| Ballard Medical Products | 2 | 1984-11-16 |
| H & P Industries, Inc. | 2 | 1983-04-06 |
| M-Pact Worldwide Management Corp. | 1 | 1997-07-07 |
20 more applicants have GEC clearances. See the full list in Caduvo.
Most recent GEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971473 | M-Pact Worldwide Management Corp. | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | 1997-07-07 | 75 |
| K960621 | Shippert Medical Technologies Corp. | EXPANDACELL INSTRUMENT WIPE | 1996-04-01 | 48 |
| K900691 | Bio-Dyne, Inc. | BIODYNE INSTRUMENT WIPES | 1990-03-08 | 23 |
| K896085 | Sparta Surgical Corp. | SURGI-BRUSH | 1989-11-08 | 20 |
| K875033 | Medsurg Industries, Inc. | STERILE SCRUBBY SCRUB BRUSH | 1988-02-19 | 74 |
Recalls for GEC devices
openFDA lists no recalls for product code GEC.
Frequently asked questions
What is FDA product code GEC?
GEC is the FDA product code for brush, scrub, operating-room. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GEC?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEC?
Across 37 cleared submissions the average was 38 days from receipt to decision (median 29).
Which companies have the most GEC clearances?
Dexide, Inc. (10); Absorbent Cotton Co., Inc. (2); Ballard Medical Products (2); H & P Industries, Inc. (2); M-Pact Worldwide Management Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GEC
- Run a recall and safety report across every GEC manufacturer
- Watch product code GEC 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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