SPEMBLY 140 CRYOSYSTEM PROBES & TIPS
FDA 510(k) clearance K823835 · decided 1983-01-17
Clearance details
- K-number
- K823835
- Device name
- SPEMBLY 140 CRYOSYSTEM PROBES & TIPS
- Applicant
- Keller Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-21
- Decision date
- 1983-01-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- HQA
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Keller Instruments
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 |
|---|---|---|
| SERIES 25 SLIMLINE CRYO PROBES (K854422) | Keeler Instruments, Inc. | 1985-12-30 |
| KEELER-COMPACT CRYO SYSTEM (K854411) | Keeler Instruments, Inc. | 1985-12-30 |
| ACU220 CRYO UNIT (K841294) | Keller Instruments, Inc. | 1984-08-15 |
Recalls involving this device
No recalls on record reference this clearance.