A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
FDA 510(k) clearance K150924 · decided 2015-07-27
Clearance details
- K-number
- K150924
- Device name
- A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
- Applicant
- Anchor Innovation Medical (A.I.M.)
- Decision
- Substantially Equivalent
- Date received
- 2015-04-06
- Decision date
- 2015-07-27
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Rockville, MD, 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.
Recalls involving this device
No recalls on record reference this clearance.