VICO MICRO SURGICAL INSTRUMENTS
FDA 510(k) clearance K843592 · decided 1984-10-05
Clearance details
- K-number
- K843592
- Device name
- VICO MICRO SURGICAL INSTRUMENTS
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-12
- Decision date
- 1984-10-05
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- HWQ
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Visitec Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MITEK SUTURE RETROGRADER (K970360) | Mitek Products | 1997-03-10 |
| SOFT TISSUE EXPANDER (K923381) | Acufex Microsurgical, Inc. | 1993-05-05 |
| ACUFEX PASSING PINS AND SURGICAL WIRE (K920621) | Acufex Microsurgical, Inc. | 1993-05-05 |
| MENISCUS MENDER II LOOP (K885311) | Instrument Makar, Inc. | 1989-02-09 |
| SOFT-TISSUE INSTRUMENT (K841622) | Plastafil, Inc. | 1984-07-11 |
| SLOTTED SOFT-TISSUE INSTRUMENT (K841623) | Plastafil, Inc. | 1984-07-11 |
| SILASTIC TENDON PASSER H.P. (K811679) | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
| ROTH-KENNEDY PASSER (K791960) | 3M Company | 1979-10-04 |
Recalls involving this device
No recalls on record reference this clearance.