SKYTRON ELITE SURGICAL TABLES
FDA 510(k) clearance K811311 · decided 1981-06-02
Clearance details
- K-number
- K811311
- Device name
- SKYTRON ELITE SURGICAL TABLES
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-11
- Decision date
- 1981-06-02
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GBC
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Skytron
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 |
|---|---|---|
| HALUX EXLITE MINOR SURGERY LIGHT (K896961) | Jedmed Instrument Co. | 1990-02-22 |
| FLAT SUCTION DRAIN (K830610) | Sil-Med Corp. | 1983-03-29 |
| MINOR SURGERY LIGHT (K810207) | Cavitron Corp. | 1981-02-13 |
Recalls involving this device
No recalls on record reference this clearance.