CABLECAP MODEL: WLF, STZ, ACM
FDA 510(k) clearance K101496 · decided 2010-09-14
Clearance details
- K-number
- K101496
- Device name
- CABLECAP MODEL: WLF, STZ, ACM
- Applicant
- Sensormed
- Decision
- Substantially Equivalent
- Date received
- 2010-06-01
- Decision date
- 2010-09-14
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- FST
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
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| INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070) | Invuity, Inc. | 2009-04-22 |
| RETRACTOR LITE (K083710) | Thomas Surgical Instruments, Inc. | 2009-02-23 |
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Recalls involving this device
No recalls on record reference this clearance.