SUTURE REMOVAL KIT
FDA 510(k) clearance K920340 · decided 1992-04-23
Clearance details
- K-number
- K920340
- Device name
- SUTURE REMOVAL KIT
- Applicant
- Medikmark, Inc.
- Decision
- Unknown
- Date received
- 1992-01-24
- Decision date
- 1992-04-23
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645) | Avery Dennison Medical , Ltd. | 2023-10-25 |
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| HONGYU DISPOSABLE SURGICAL DRAPES (K141324) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 |
| SURGICAL DRAPE (K140195) | Griffith-Lucas, LLC | 2014-09-10 |
| 3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330) | 3M Healthcare | 2014-08-18 |
| WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438) | Whitney Medical Solutions | 2014-08-14 |
| 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250) | 3M Healthcare | 2014-07-25 |
| SURGISLEEVE WOUND PROTECTOR (K140064) | Covidien | 2014-03-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover inst recall (Z-1136-04) | Medikmark, Incorporated | 2004-07-22 |
| MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit contain recall (Z-1137-04) | Medikmark, Incorporated | 2004-07-22 |
| Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gau recall (Z-1138-04) | Medikmark, Incorporated | 2004-07-22 |