OPSITE SPECIALITY DRAPES
FDA 510(k) clearance K872757 · decided 1987-07-28
Clearance details
- K-number
- K872757
- Device name
- OPSITE SPECIALITY DRAPES
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-13
- Decision date
- 1987-07-28
- Days to decision
- 15 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
- Massillon, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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 |
| 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578) | 3M Company | 2023-05-18 |
| BeneHold Surgical Incise Drape with CHG antimicrobial (K202208) | Avery Dennison Belgie Bvba | 2021-07-30 |
| ControlRad Sterile Cover (K200238) | Controlrad, Inc. | 2020-04-26 |
| MediClear PreOp (K163556) | Covalontechnologies, Inc. | 2017-09-14 |
| Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080) | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |