510(k) K240185
- Device
- Cypris eXact Suture Placement Device
- Applicant
- Cypris Medical
- 510(k) number
- K240185
- Product code
- GEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-03
- Date received
- 2024-01-23
- Regulation
- 878.4800
- Classification name
- Carrier, Ligature
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dan Holton
- Address
- 4541 N. Ravenswood Ave., #202 Chicago IL US 60640 60640
FDA Registration Numbers#
- 1225691
- 2529846
- 3017540705
- 3024987432
- 3011981870
- 3008936260
- 9710524
- 3003418325
- 1836161
- 3008717566
- 3016069968
- 1923569
- 3005049530
- 9610612
- 3006554912
- 2244478
- 1043214
- 3013497507
- 1219518
- 3023657851
- 1421879
- 3005108347
- 3013354263
- 9611112
- 3004986960
- 9612074
- 8010547
- 8040278
- 3005528784
- 9611503
- 1424263
- 3014644369
- 3007137643
- 3023244395
- 1417592
- 3011024991
- 3007597038
- 9612278
- 3033536312
- 3005809810
- 3012995405
- 1825146
- 3014579161
- 3010692967
- 1644312
- 3008770252
- 3004193466
- 8030607
- 1416605
- 2084346
- 3005067367
- 1056350
- 3010353847
- 3009968482
- 1421101
- 3003807268
- 3009513193
- 3004135030
- 3008808049
- 3007648354
- 1820334
- 3011137372
- 9611278
- 8010099
- 8010422
- 8040233
- 8010155
- 3010041511
- 3001620590
- 3003877407
- 3004365956
- 9680260
Source Documents#
Other 510(k) Records For Product Code GEJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900958 | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Solos Endoscopy, Inc. | 1990-04-18 |
| K884553 | STAMEY NEEDLE | Cook Ob/Gyn | 1988-11-14 |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Cox-Uphuff Intl. | 1987-11-13 |