DEEP SUTURE
FDA 510(k) clearance K942818 · decided 1994-08-25
Clearance details
- K-number
- K942818
- Device name
- DEEP SUTURE
- Applicant
- Automated Medical Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-15
- Decision date
- 1994-08-25
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- MDM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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| SAPHLIFT (K990062) | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (K981579) | ETHICON, Inc. | 1998-07-09 |
| TUNNELER (K943968) | Denver Biomedicals, Inc. | 1995-03-01 |
| DERMAVBLADE(TM) (K945430) | Hasting'S Biomedical Corp. | 1994-11-28 |
| EAST WEST INSTRUMENTS (K941193) | East West Instruments, Inc. | 1994-11-09 |
Recalls involving this device
No recalls on record reference this clearance.