MICRA MICROSURGICAL INSTRUMENTS
FDA 510(k) clearance K862971 · decided 1986-08-25
Clearance details
- K-number
- K862971
- Device name
- MICRA MICROSURGICAL INSTRUMENTS
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-06
- Decision date
- 1986-08-25
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- GZX
- Device class
- 1
- Regulation number
- 882.4525
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami, FL, 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 |
| 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 |
| UNIVERSAL INSTRU. SET FOR NEUROVASCULAR (K831071) | Prothia USA, Inc. | 1983-06-08 |
| DUJOVNY MICROSURGICAL SCISSORS (K810485) | American V. Mueller | 1981-02-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |