FDA product code ILG: Stocking, Elastic
ILG is the FDA product code for stocking, elastic. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 8 510(k) submissions under ILG, from 8 different applicants. The average 510(k) review took 17 days (median 13). FDA has posted 3 recalls for ILG devices.
Classification
| Field | Value |
|---|---|
| Device name | Stocking, Elastic |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ILG clearance
Top ILG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northern Medical Surgical, Inc. | 1 | 1983-11-03 |
| Fred Sammons, Inc. | 1 | 1983-06-08 |
| Abco Dealers, Inc. | 1 | 1978-04-19 |
| Alba-Waldensian, Inc. | 1 | 1978-04-10 |
| Convertors | 1 | 1977-03-07 |
3 more applicants have ILG clearances. See the full list in Caduvo.
Most recent ILG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833437 | Northern Medical Surgical, Inc. | ORTHOPEDIC STOCKINETTE | 1983-11-03 | 29 |
| K831540 | Fred Sammons, Inc. | COMPRESSOGRIP ELASTIC STUMP SHRINKER# | 1983-06-08 | 27 |
| K780612 | Abco Dealers, Inc. | STOCKINETTE, STERILE | 1978-04-19 | 9 |
| K780547 | Alba-Waldensian, Inc. | STERILE ORTHOPEDIC STOCKINETTE | 1978-04-10 | 5 |
| K770346 | Convertors | ORTHOPEDIC STOCKINETTE | 1977-03-07 | 13 |
Recalls for ILG devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-25.
| Year | Recalls |
|---|---|
| 2021 | 3 |
Frequently asked questions
What is FDA product code ILG?
ILG is the FDA product code for stocking, elastic. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ILG?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILG?
Across 8 cleared submissions the average was 17 days from receipt to decision (median 13).
Which companies have the most ILG clearances?
Northern Medical Surgical, Inc. (1); Fred Sammons, Inc. (1); Abco Dealers, Inc. (1); Alba-Waldensian, Inc. (1); Convertors (1).
Have ILG devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2021-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code ILG
- Run a recall and safety report across every ILG manufacturer
- Watch product code ILG 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times