Cypris eXact Suture Placement Device
FDA 510(k) clearance K240185 · decided 2024-05-03
Clearance details
- K-number
- K240185
- Device name
- Cypris eXact Suture Placement Device
- Applicant
- Cypris Medical
- Decision
- Substantially Equivalent
- Date received
- 2024-01-23
- Decision date
- 2024-05-03
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- GEJ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chicago, IL, 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 |
|---|---|---|
| GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (K900958) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED (K900959) | Solos Endoscopy, Inc. | 1990-04-18 |
| STAMEY NEEDLE (K884553) | Cook Ob/Gyn | 1988-11-14 |
| LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (K874342) | Cox-Uphuff Intl. | 1987-11-13 |
Recalls involving this device
No recalls on record reference this clearance.