FDA product code LRY: Punch, Surgical
LRY is the FDA product code for punch, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under LRY, from 5 different applicants. The average 510(k) review took 84 days (median 34). FDA has posted 6 recalls for LRY devices.
Classification
| Field | Value |
|---|---|
| Device name | Punch, Surgical |
| 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 LRY clearance
Top LRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Tool, Inc. | 3 | 1987-11-23 |
| Acuderm, Inc. | 1 | 1994-03-24 |
| Kramer Const | 1 | 1991-03-06 |
| Lipogen, Inc. | 1 | 1990-06-28 |
| Premier Medical | 1 | 1990-02-13 |
Most recent LRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933516 | Acuderm, Inc. | ACU-E PUNCH | 1994-03-24 | 247 |
| K904869 | Kramer Const | ELLIPSE PUNCH | 1991-03-06 | 128 |
| K902636 | Lipogen, Inc. | LIPOGEN RHEUMELISA DSDNA ASSAY | 1990-06-28 | 14 |
| K896303 | Premier Medical | BIOPSY PUNCH | 1990-02-13 | 106 |
| K874356 | Med-Tool, Inc. | PIN PUNCH | 1987-11-23 | 31 |
Recalls for LRY devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LRY?
LRY is the FDA product code for punch, surgical. 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 LRY?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRY?
Across 7 cleared submissions the average was 84 days from receipt to decision (median 34).
Which companies have the most LRY clearances?
Med-Tool, Inc. (3); Acuderm, Inc. (1); Kramer Const (1); Lipogen, Inc. (1); Premier Medical (1).
Have LRY devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2017-10-23.
Next steps
- Run an FDA pathway report with predicate devices for product code LRY
- Run a recall and safety report across every LRY manufacturer
- Watch product code LRY 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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