Coaptite Tissue Marker and Coaptite FN Tissue Marker
FDA 510(k) K012955 · Bioform, Inc.
510(k) numberK012955
Submission
- Device name
- Coaptite Tissue Marker and Coaptite FN Tissue Marker
- Applicant
- Bioform, Inc.
Franksville, WI, US - Received
- September 4, 2001
- Decision date
- October 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033398 | Laryngeal Augmentation ImplantMIX · Traditional | 12/12/2003SE |
| K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3LYC · Traditional | 06/27/2003SE |
| K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1KHJ · Traditional | 01/09/2002SE |
Questions and answers
When was Coaptite Tissue Marker and Coaptite FN Tissue Marker cleared by the FDA?
Coaptite Tissue Marker and Coaptite FN Tissue Marker (K012955) received a 510(k) decision of Substantially Equivalent on October 22, 2001, 48 days after the submission was received.
What is the product code of K012955?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.