UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
FDA 510(k) clearance K831071 · decided 1983-06-08
Clearance details
- K-number
- K831071
- Device name
- UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
- Applicant
- Prothia USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-04
- Decision date
- 1983-06-08
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GZX
- Device class
- 1
- Regulation number
- 882.4525
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- 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 |
|---|---|---|
| MICROSURGICAL INSTRUMENTS (K932169) | American Russian Medical Services, Inc. | 1993-07-20 |
| CLARUS ENDOSCOPIC BALL PROBE (K926048) | Clarus Medical Systems, Inc. | 1993-04-07 |
| J105 JAMES SURGICAL SYSTEM I/A PACK (K911932) | O.R. Specialties, Inc. | 1991-08-26 |
| MICROSURGICAL KERATOME (K890216) | Kinetic Medical Products | 1989-02-16 |
| RANGE OF CROCODILE ACTION INSTRUMENTS (K873934) | Downs Surgical , Ltd. | 1987-12-17 |
| RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (K873933) | Downs Surgical , Ltd. | 1987-12-17 |
| MICRA MICROSURGICAL INSTRUMENTS (K862971) | Cordis Corp. | 1986-08-25 |
| THE VICKERS STANDARD MICROSURGERY SET (K853161) | Keeler Instruments, Inc. | 1985-11-07 |
| VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (K853179) | Keeler Instruments, Inc. | 1985-11-07 |
| VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (K853180) | Keeler Instruments, Inc. | 1985-10-28 |
| VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (K853181) | Keeler Instruments, Inc. | 1985-10-28 |
| DUJOVNY MICROSURGICAL SCISSORS (K810485) | American V. Mueller | 1981-02-27 |
Recalls involving this device
No recalls on record reference this clearance.