VISECERA RETAINER
FDA 510(k) clearance K802806 · decided 1981-01-23
Clearance details
- K-number
- K802806
- Device name
- VISECERA RETAINER
- Applicant
- Adept-Med Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-07
- Decision date
- 1981-01-23
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GCZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| JAIN GRAFT ASSIST (K904536) | Jain Surgical Equipment, Inc. | 1990-11-29 |
| ADAMS BREAST IMPLANT PROTECTOR (K893870) | Adept-Med Intl., Inc. | 1989-07-14 |
| MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809) | Adept-Med Intl., Inc. | 1987-03-19 |
| CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR (K801610) | Edward Weck, Inc. | 1980-08-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 32 recall (Z-1156-06) | Adept-Med International Inc | 2006-06-22 |