JOK · Scissors, Medical, Disposable
General Hospital · 21 CFR 880.6820 · Class 1
Overview
| Product Code | JOK |
|---|---|
| Device Name | Scissors, Medical, Disposable |
| Regulation | 21 CFR 880.6820 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K855131 | SUTURE REMOVAL KIT | Dynarex Corp. | Jan 13, 1986 | SESE |
| K843075 | UTILITY SCISSORS DISPOSABLE ITEMS | Greene International Corp. | Sep 5, 1984 | SESE |
| K812555 | DISPOSABLE SUTURE REMOVAL SCISSORS | Medcare Products | Nov 16, 1981 | SESE |
| K770595 | SUTURE REMOVAL SET | Abco Dealers, Inc. | May 23, 1977 | SESE |
| K770481 | SHEAR, PLASTIC HANDLE UTILITY S-475-7 | Acme United Corp. | Apr 29, 1977 | SESE |
| K770163 | SUTURE CUTTER | Concept, Inc. | Mar 30, 1977 | SESE |
| K761192 | DRESSING CHANGE KIT | Superior Plastic Products Corp. | Feb 28, 1977 | SESE |
Top Applicants
- Abco Dealers, Inc. — 1 clearance
- Acme United Corp. — 1 clearance
- Concept, Inc. — 1 clearance
- Dynarex Corp. — 1 clearance
- Greene International Corp. — 1 clearance
