FDA product code LRW: Scissors, General, Surgical
LRW is the FDA product code for scissors, general, 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 18 510(k) submissions under LRW, from 11 different applicants. The average 510(k) review took 30 days (median 24). FDA has posted 20 recalls for LRW devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, General, 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 LRW clearance
Top LRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 4 | 1989-04-12 |
| Solos Endoscopy, Inc. | 2 | 1990-04-18 |
| Kinetic Medical Products | 2 | 1989-02-03 |
| Micrins, Ltd. | 2 | 1988-11-08 |
| Artiberia | 2 | 1985-06-20 |
6 more applicants have LRW clearances. See the full list in Caduvo.
Most recent LRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911158 | Northgate Technologies, Inc. | MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM | 1991-03-29 | 14 |
| K902828 | Orion Life Systems, Inc. | SUTURE REMOVAL TRAY | 1990-08-08 | 41 |
| K900957 | Solos Endoscopy, Inc. | GS-2100 HOOK SUTURE SCISSOR, 5MM | 1990-04-18 | 50 |
| K900950 | Solos Endoscopy, Inc. | GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM | 1990-04-18 | 50 |
| K892823 | The South India Surgical Co. Pvt. , Ltd. | PLASTER CUTTING SCISSORS | 1989-05-25 | 44 |
Recalls for LRW devices
20 product recalls in 13 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-11-13.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LRW?
LRW is the FDA product code for scissors, general, 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 LRW?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRW?
Across 18 cleared submissions the average was 30 days from receipt to decision (median 24).
Which companies have the most LRW clearances?
Zinnanti Surgical Instruments, Inc. (4); Solos Endoscopy, Inc. (2); Kinetic Medical Products (2); Micrins, Ltd. (2); Artiberia (2).
Have LRW devices been recalled?
Yes: 20 product recalls across 13 recall events; the most recent began 2025-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LRW
- Run a recall and safety report across every LRW manufacturer
- Watch product code LRW 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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