FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TITANIUM LIGATING CLIPS
K Number: K896262
·
Decision Jan 2, 1990
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
3
Applicant Total
33
Review Days
64
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Basic Information
- Device Name
- TITANIUM LIGATING CLIPS
- K Number
- K896262
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Richard-Allan Medical Ind., Inc.
- Date Received
- October 30, 1989
- Decision Date
- January 2, 1990
- Product Code
- HBT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBT | Applier, Hemostatic Clip | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBT), ordered by most recent decision date.
REFLEX(R) ECA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Richard-Allan Medical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931879 | REFLEX HTR | Mar 24, 1994 | Substantially Equivalent |
| K924200 | REFLEX(R) ESC | Feb 22, 1994 | Substantially Equivalent |
| K926297 | REFLEX ESI | Oct 15, 1993 | Substantially Equivalent |
| K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | Apr 20, 1993 | Substantially Equivalent |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | May 3, 1990 | Substantially Equivalent |
| K890314 | PROTECTOR (SURGICAL INSTRUMENT) | Feb 27, 1989 | Substantially Equivalent |
| K873309 | REFLEX(TM) CA-T CLIP APPLIER | Nov 27, 1987 | Substantially Equivalent |
| K862404 | REFLEX(TM) CLIP APPLIER | Jul 23, 1986 | Substantially Equivalent |
| K862223 | MICRO THIN* PARAFFIN | Jun 17, 1986 | Substantially Equivalent |
| K861890 | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | Jun 3, 1986 | Substantially Equivalent |