ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
FDA 510(k) clearance K800552 · decided 1980-03-20
Clearance details
- K-number
- K800552
- Device name
- ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-10
- Decision date
- 1980-03-20
- Days to decision
- 10 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Carl Zeiss
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |