DISARP ORIGINAL
FDA 510(k) clearance K802248 · decided 1980-09-26
Clearance details
- K-number
- K802248
- Device name
- DISARP ORIGINAL
- Applicant
- Unoplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1980-09-16
- Decision date
- 1980-09-26
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- GAO
- Device class
- 2
- Regulation number
- 878.4495
- 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 |
|---|---|---|
| LABELING FOR MYO/WIRE II STERNOTOMY SUTURES (K932513) | Alto Development Corp. | 1994-01-07 |
| AUTO SUTURE STAINLESS STEEL SUTURES* (K872532) | United States Surgical, A Division of Tyco Healthc | 1987-08-05 |
| SHARPOINT STAINLESS STEEL SUTURE (K863034) | Chathamborough Research Group, Inc. | 1986-09-30 |
Recalls involving this device
No recalls on record reference this clearance.