Product code GCZ
- Device name
- Retainer, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- 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 |
|---|---|---|---|
| K904536 | JAIN GRAFT ASSIST | Jain Surgical Equipment, Inc. | 1990-11-29 |
| K893870 | ADAMS BREAST IMPLANT PROTECTOR | Adept-Med Intl., Inc. | 1989-07-14 |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | Adept-Med Intl., Inc. | 1987-03-19 |
| K802806 | VISECERA RETAINER | Adept-Med Intl., Inc. | 1981-01-23 |
| K801610 | CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR | Edward Weck, Inc. | 1980-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00843511123147 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123130 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123086 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123093 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123109 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123116 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00843511123123 | Omnia Medical TiBrid™- A/SA | OMNIA MEDICAL, LLC | 2023-10-18 |
| 00613244000011 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 61324400006600 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000059 | Breast Implant Protector | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 61324400004200 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 61324400003500 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 61324400002800 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 61324400001100 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000004 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000066 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000042 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000035 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
| 00613244000028 | Viscera Retainer, Fish | ADEPT MED INTERNATIONAL INC | 2023-02-16 |
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| 90841823104277 | Anchor Bolt Kit, LSB Style | AD-TECH MEDICAL INSTRUMENT CORPORATION | 2021-08-10 |
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| 90841823104291 | Anchor Bolt Kit, LSB Style | AD-TECH MEDICAL INSTRUMENT CORPORATION | 2021-08-10 |
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| 00857180007714 | Viscera Retainer Radiopaque Center Spine | RAINBOW MEDICAL DEVICES LLC | 2019-01-15 |
| 00857180007615 | Viscera Retainer Radiopaque Center Spine | RAINBOW MEDICAL DEVICES LLC | 2019-01-15 |
| 00857180007417 | Viscera Retainer Radiopaque Center Spine | RAINBOW MEDICAL DEVICES LLC | 2019-01-15 |
| 00857180007219 | Viscera Retainer Radiopaque Center Spine | RAINBOW MEDICAL DEVICES LLC | 2019-01-15 |
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| 09349967000700 | LapPakOR | THE O R COMPANY PTY LTD | 2018-06-23 |