FDA product code JOK: Scissors, Medical, Disposable
JOK is the FDA product code for scissors, medical, disposable. It is a Class I device, regulated under 21 CFR 880.6820 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under JOK, from 7 different applicants. The average 510(k) review took 53 days (median 56). FDA has posted 3 recalls for JOK devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Medical, Disposable |
| Device class | Class I |
| Regulation | 21 CFR 880.6820 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JOK clearance
Top JOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynarex Corp. | 1 | 1986-01-13 |
| Greene International Corp. | 1 | 1984-09-05 |
| Medcare Products | 1 | 1981-11-16 |
| Abco Dealers, Inc. | 1 | 1977-05-23 |
| Acme United Corp. | 1 | 1977-04-29 |
2 more applicants have JOK clearances. See the full list in Caduvo.
Most recent JOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K855131 | Dynarex Corp. | SUTURE REMOVAL KIT | 1986-01-13 | 21 |
| K843075 | Greene International Corp. | UTILITY SCISSORS DISPOSABLE ITEMS | 1984-09-05 | 30 |
| K812555 | Medcare Products | DISPOSABLE SUTURE REMOVAL SCISSORS | 1981-11-16 | 69 |
| K770595 | Abco Dealers, Inc. | SUTURE REMOVAL SET | 1977-05-23 | 56 |
| K770481 | Acme United Corp. | SHEAR, PLASTIC HANDLE UTILITY S-475-7 | 1977-04-29 | 49 |
Recalls for JOK devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-04-30.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code JOK?
JOK is the FDA product code for scissors, medical, disposable. It is a Class I device, regulated under 21 CFR 880.6820 and reviewed by the General Hospital panel.
What device class is JOK?
Class I, regulation 21 CFR 880.6820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JOK?
Across 7 cleared submissions the average was 53 days from receipt to decision (median 56).
Which companies have the most JOK clearances?
Dynarex Corp. (1); Greene International Corp. (1); Medcare Products (1); Abco Dealers, Inc. (1); Acme United Corp. (1).
Have JOK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JOK
- Run a recall and safety report across every JOK manufacturer
- Watch product code JOK 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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