FDA product code HRR: Scissors, Orthopedic, Surgical
HRR is the FDA product code for scissors, orthopedic, surgical. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under HRR, from 5 different applicants. The average 510(k) review took 34 days (median 31). FDA has posted 1 recall for HRR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Orthopedic, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRR clearance
Top HRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 3 | 1989-01-27 |
| Arthropedics, Inc. | 2 | 1987-11-02 |
| Artiberia | 1 | 1985-06-20 |
| All-Hands Medical Supply, Inc. | 1 | 1984-08-21 |
| Edward Weck, Inc. | 1 | 1980-05-08 |
Most recent HRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890261 | Kinetic Medical Products | TRIGEMINAL SCISSORS | 1989-01-27 | 9 |
| K890212 | Kinetic Medical Products | MICROSURGICAL SCISSORS | 1989-01-27 | 9 |
| K890225 | Kinetic Medical Products | SURGICAL SCISSORS | 1989-01-27 | 9 |
| K873501 | Arthropedics, Inc. | SCISSOR, LEFT | 1987-11-02 | 63 |
| K873502 | Arthropedics, Inc. | SCISSOR, RIGHT | 1987-11-02 | 63 |
Recalls for HRR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-12.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code HRR?
HRR is the FDA product code for scissors, orthopedic, surgical. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HRR?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRR?
Across 8 cleared submissions the average was 34 days from receipt to decision (median 31).
Which companies have the most HRR clearances?
Kinetic Medical Products (3); Arthropedics, Inc. (2); Artiberia (1); All-Hands Medical Supply, Inc. (1); Edward Weck, Inc. (1).
Have HRR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HRR
- Run a recall and safety report across every HRR manufacturer
- Watch product code HRR 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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