Product code LWH
- Device name
- Counter, Sponge, Surgical
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.2740
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121274 | PIXEL APP | Gauss Surgical, Inc., | 2012-06-27 |
| K120473 | PIXEL APP | Gauss Surgical, Inc., | 2012-04-09 |
| K100551 | ORLOCATE SYSTEM MODEL ORL 100 | Haldor Advanced Technologies, Ltd. | 2010-08-12 |
| K093557 | SMARTWAND-DTX | Clearcount Medical Solutions | 2009-12-18 |
| K073180 | SMARTSPONGE PLUS SYSTEM | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| K071355 | SMARTSPONGE SYSTEM | Clearcount Medical Solutions, Inc. | 2007-05-24 |
| K061316 | MEDLINE SURGICAL SPONGE SCANNER | Medline Industries, Inc. | 2006-11-02 |
| K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | Rf Surgical Systems, Inc. | 2006-11-02 |
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM | Surgicount Medical | 2006-03-14 |
| K982260 | MARKWELL GAUZE SPONGE | Markwell Intl., Inc. | 1998-08-12 |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | 1997-07-25 |
| K945144 | SPONGE COUNT | Michael Fischer Assoc. | 1995-01-12 |
| K912824 | DEVON SPONGE COUNTER BAGS | Devon Industries, Inc. | 1991-08-26 |
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Gorsk, Inc. | 1987-10-23 |
| K790538 | SPONGE COUNTER | Devon Industries, Inc. | 1979-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 37613327517973 | SURGICOUNT | STRYKER CORPORATION | 2021-07-08 |
| 16931918140452 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2021-04-24 |
| 30080196324495 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 30885632125939 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-23 |
| 30885632125922 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-23 |
| 07613327509106 | N/A | STRYKER CORPORATION | 2020-04-17 |
| 10686864042799 | AMD-RITMED | AMD Medicom Inc | 2019-01-16 |
| 10686864048029 | AMD-RITMED | AMD Medicom Inc | 2019-01-16 |
| 10686864048036 | AMD-RITMED | AMD Medicom Inc | 2019-01-16 |
| 10884521700727 | Situate | Covidien LP | 2018-10-13 |
| M684PPW383741 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383021 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383061 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383801 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383781 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383761 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383281 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383721 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383701 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383651 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383641 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383631 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383621 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383611 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383601 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383581 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| M684PPW383361 | Profemur | Microport Orthopedics Inc. | 2016-08-31 |
| 20809160022204 | Novaplus® | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 20809160023140 | SafeTCount™ | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 20809160023195 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |