Titanium Ligating Clips
FDA 510(k) K896262 · Richard-Allan Medical Ind., Inc.
510(k) numberK896262
Submission
- Device name
- Titanium Ligating Clips
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- October 30, 1989
- Decision date
- January 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HBT – Applier, Hemostatic Clip
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924929 | Reflex(R) EcaHBT · Traditional | Richard-Allan Medical | 07/21/1993SE |
| K862696 | Temporary Hemo Clip, 07-096-01/02 & Apply ForcepHBT · Traditional | Downs Surgical , Ltd. | 07/30/1986SE |
| K800318 | Doubletime 2-TIPPED Appliers for HemocliHBT · Traditional | Edward Weck, Inc. | 03/10/1980SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K924200 | Reflex(R) EscKNF · Traditional | 02/22/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | 02/27/1989SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | 06/17/1986SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | 06/03/1986SE |
Questions and answers
When was Titanium Ligating Clips cleared by the FDA?
Titanium Ligating Clips (K896262) received a 510(k) decision of Substantially Equivalent on January 2, 1990, 64 days after the submission was received.
What is the product code of K896262?
The FDA product code is HBT – Applier, Hemostatic Clip, a Class I (low risk) device regulated under 21 CFR 878.4800.