SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
FDA 510(k) clearance K932653 · decided 1994-01-28
Clearance details
- K-number
- K932653
- Device name
- SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
- Applicant
- Carapace, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1994-01-28
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- LGH
- Device class
- 1
- Regulation number
- 888.5960
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Broken Arrow, OK, 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 |
|---|---|---|
| CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (K901677) | Buckman Co., Inc. | 1990-04-23 |
| QCR SYSTEM I AND QCR SYSTEM II (K893380) | Bremer Mfg. & Tool Co., Inc. | 1989-11-16 |
| DELTA-TECH(TM) CAST REMOVAL SYSTEM (K895861) | Johnson & Johnson Professionals, Inc. | 1989-10-19 |
| PLASTER VACUUM, 230V MODEL NO. 4183-161 (K873723) | Martin Medical | 1987-12-10 |
| PLASTER VACUUM, 115V MODEL NO. 4183-160 (K873721) | Martin Medical | 1987-12-07 |
| CAST CUTTER, 115V MODEL NO. 4183-106 (K873719) | Martin Medical | 1987-10-02 |
| CAST CUTTER, 230V MODEL NO. 4183-107 (K873720) | Martin Medical | 1987-10-02 |
| CAST CUTTER/CAST SAW/INSTRUMENT (K820351) | Black & Decker(Tm) | 1982-03-02 |
Recalls involving this device
No recalls on record reference this clearance.