FDA product code LGG: Instrument, Cast Application/Removal, Manual
LGG is the FDA product code for instrument, cast application/removal, manual. It is a Class I device, regulated under 21 CFR 888.5980 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under LGG, from 3 different applicants. The average 510(k) review took 47 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Cast Application/Removal, Manual |
| Device class | Class I |
| Regulation | 21 CFR 888.5980 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LGG clearance
Top LGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 1 | 1987-01-28 |
| Artiberia | 1 | 1985-07-09 |
| Buckman Co., Inc. | 1 | 1984-01-30 |
Most recent LGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870100 | Orthopedic Systems, Inc. | PLASTER STAND | 1987-01-28 | 19 |
| K851786 | Artiberia | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | 1985-07-09 | 75 |
| K834384 | Buckman Co., Inc. | MODULAR EXTREMITY CASTING SUPPORT | 1984-01-30 | 47 |
Recalls for LGG devices
openFDA lists no recalls for product code LGG.
Frequently asked questions
What is FDA product code LGG?
LGG is the FDA product code for instrument, cast application/removal, manual. It is a Class I device, regulated under 21 CFR 888.5980 and reviewed by the Orthopedic panel.
What device class is LGG?
Class I, regulation 21 CFR 888.5980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGG?
Across 3 cleared submissions the average was 47 days from receipt to decision (median 47).
Which companies have the most LGG clearances?
Orthopedic Systems, Inc. (1); Artiberia (1); Buckman Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGG
- Run a recall and safety report across every LGG manufacturer
- Watch product code LGG 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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