Ligature Carrier/Packer, Hydroxylapatite
FDA 510(k) K874342 · Cox-Uphuff Intl.
510(k) numberK874342
Submission
- Device name
- Ligature Carrier/Packer, Hydroxylapatite
- Applicant
- Cox-Uphuff Intl.
Santa Barbara, CA, US - Received
- October 20, 1987
- Decision date
- November 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEJ – Carrier, Ligature
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240185 | Cypris eXact Suture Placement DeviceGEJ · Traditional | Cypris Medical | 05/03/2024SE |
| K900959 | GS-1400 Toothed Dissecting Forcep, 5MM, InsulatedGEJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900958 | GS-1300 Atraumatic Grasping Forcep, Curved, 10MMGEJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K884553 | Stamey NeedleGEJ · Traditional | Cook Ob/Gyn | 11/14/1988SE |
More from Cook Ob/Gyn
| 510(k) | Device | Decision |
|---|---|---|
| K874276 | Cui, Versafil(Tm), Ste(Tm) Tissue ExpanderFZW · Traditional | 12/02/1987SE |
| K873470 | TemplateFTY · Traditional | 09/08/1987SE |
| K865056 | Cui Tissue Expander Versafil(Tm) Tissue ExpanderLCJ · Traditional | 05/22/1987SE |
| K871200 | Cui Nasal Septum ButtonLFB · Traditional | 04/15/1987SE |
| K865033 | Breast Prosthesis (Non & Inflatable) Skin ExpanderLCJ · Traditional | 01/12/1987SE |
| K854339 | Cui Chin Sizer · Traditional | 11/15/1985SE |
| K853945 | Cui Rhinoplasty ImplantsFZE · Traditional | 10/18/1985SE |
| K831566 | Cui Mammary Prothesis SizerMRD · Traditional | 08/12/1983SE |
| K813394 | DS-7 Closed Wound Suction Drain SystemGCX · Traditional | 01/22/1982SE |
| K802214 | Cos-Uphoff Int'L DS-5 Drainage SystemGCY · Traditional | 10/23/1980SE |
Questions and answers
When was Ligature Carrier/Packer, Hydroxylapatite cleared by the FDA?
Ligature Carrier/Packer, Hydroxylapatite (K874342) received a 510(k) decision of Substantially Equivalent on November 13, 1987, 24 days after the submission was received.
What is the product code of K874342?
The FDA product code is GEJ – Carrier, Ligature, a Class I (low risk) device regulated under 21 CFR 878.4800.