SUTURE REMOVAL PAK
FDA 510(k) clearance K801746 · decided 1980-08-20
Clearance details
- K-number
- K801746
- Device name
- SUTURE REMOVAL PAK
- Applicant
- Devco Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-28
- Decision date
- 1980-08-20
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- FZT
- 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 |
|---|---|---|
| SMARTSHEARS (K112400) | Nuscience Consulting and Management Group, LLC | 2011-09-12 |
| AUTO SUTURE DISPOSABLE SURGICAL TROCAR* (K890818) | United States Surgical, A Division of Tyco Healthc | 1989-05-04 |
| MICRINS SURGICAL SCISSOR (K872990) | Micrins Surgical, Inc. | 1987-08-17 |
| SINGLE HAIR TRANSPLANT GRAFT (K841741) | Paris Products, Inc. | 1984-07-23 |
| SPC DISPOSABLE CUTTER (K841247) | Surgical Products Corp. | 1984-05-02 |
| SCISSORS, VARIOUS (K822448) | J. Sklar Mfg. Co., Inc. | 1982-09-14 |
| SURGICAL SCISSORS, SET OF 3 (K821632) | Fred Sammons, Inc. | 1982-06-24 |
| CONPHAR LITTAUER SCISSORS (K821355) | Conphar, Inc. | 1982-05-27 |
| CONPHAR IRIS SCISSORS (K821352) | Conphar, Inc. | 1982-05-27 |
| CONPHAR TONSIL SCISSORS (K821361) | Conphar, Inc. | 1982-05-27 |
| CONPHAR WIRE CUTTING SCISSORS (K821350) | Conphar, Inc. | 1982-05-27 |
| CONPHAR DISSECTING SCISSORS (K821351) | Conphar, Inc. | 1982-05-27 |
Recalls involving this device
No recalls on record reference this clearance.