ISOLATION BAG 3M
FDA 510(k) clearance K832318 · decided 1983-10-31
Clearance details
- K-number
- K832318
- Device name
- ISOLATION BAG 3M
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1983-07-15
- Decision date
- 1983-10-31
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- KGY
- Device class
- 1
- Regulation number
- 878.4100
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Monrovia, CA, 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 |
|---|---|---|
| GOODMAN BANDAGE (K933085) | Megadyne Medical Products, Inc. | 1993-12-23 |
| TROCAR CATHETER (K913678) | Medovations, Inc. | 1991-12-16 |
| SURGICAL TISSUE POUCH (K910914) | Cook Urological, Inc. | 1991-03-28 |
| BAND-AID BRAND TRICOT MESH BANDAGES (K801823) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
| BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |