Spembly Medical, Ltd.
Mchenry, IL, US
Spembly Medical , Ltd. appears in FDA device records in Mchenry, IL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Spembly Medical, Ltd. between 1976 and 1993. The busiest year on record is 1983, with 5. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 1 |
| 1983 | 5 |
| 1984 | 1 |
| 1988 | 4 |
| 1990 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K925129 | SELECTOR | GCJ | Substantially Equivalent | |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | HPS | Substantially Equivalent | |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | LFL | Substantially Equivalent | |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | GEH | Substantially Equivalent | |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | GEH | Substantially Equivalent | |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | GEH | Substantially Equivalent | |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | HQO | Substantially Equivalent | |
| K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS | GZJ | Substantially Equivalent | |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | GEH | Substantially Equivalent | |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | GEH | Substantially Equivalent | |
| K832140 | CRYOMEDICS 5000 CRYOPROBES | GEH | Substantially Equivalent | |
| K831963 | CRYOMEDICS NEUROSTAT | GXH | Substantially Equivalent | |
| K831950 | PULSAR #B SINGLE CHANNEL TENS-PULSAR D | GZJ | Substantially Equivalent | |
| K802063 | SPEMBLY 9000 & 9300 | GZJ | Substantially Equivalent | |
| K781302 | NEUROSTAT, LLOYD | GXH | Substantially Equivalent | |
| K770058 | PROBE, VACUUM INSULATED, SERIES 30 | GEH | Substantially Equivalent | |
| K760953 | DEEP FREEZE SYSTEM (DFS-30) | GEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain