FDA product code GES: Blade, Scalpel
GES is the FDA product code for blade, scalpel. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 48 510(k) submissions under GES, from 37 different applicants. The average 510(k) review took 39 days (median 28). FDA has posted 13 recalls for GES devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Blade, Scalpel |
| 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 GES clearance
Top GES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aeroceuticals | 4 | 1977-03-30 |
| Medelec Intl. Corp. | 3 | 1985-12-24 |
| Imm Enterprises , Ltd. | 3 | 1984-01-27 |
| American Safety Razor Co. | 2 | 1987-09-04 |
| Keisei Medical Industrial Co., Ltd. | 2 | 1986-09-02 |
32 more applicants have GES clearances. See the full list in Caduvo.
Most recent GES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032242 | Omi Manufacturing Pty., Ltd. | PERSONNA PLUS SAFETY SCALPEL SYSTEM | 2003-09-23 | 64 |
| K932998 | Devon Industries, Inc. | EASY-ON | 1993-08-18 | 61 |
| K923170 | Innovative Surgical Technology, Inc. | LOS ALAMOS RETRACTABLE KNIFE | 1993-02-18 | 234 |
| K915119 | Intergrated Visual, Inc. | SCALPEL BLADE REMOVER (BLADEGARD) | 1992-05-05 | 174 |
| K911913 | Bd Becton Dickinson Vacutainer Systems Preanalytic | PRECISION GLIDE - ENHANCED SURGICAL BLADE | 1991-05-13 | 13 |
Recalls for GES devices
13 product recalls in 9 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-27.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code GES?
GES is the FDA product code for blade, scalpel. 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 GES?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GES?
Across 48 cleared submissions the average was 39 days from receipt to decision (median 28).
Which companies have the most GES clearances?
Aeroceuticals (4); Medelec Intl. Corp. (3); Imm Enterprises , Ltd. (3); American Safety Razor Co. (2); Keisei Medical Industrial Co., Ltd. (2).
Have GES devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2022-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code GES
- Run a recall and safety report across every GES manufacturer
- Watch product code GES 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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