FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLE HOLDER, MICROVASCULAR
K Number: K771859
·
Decision Oct 4, 1977
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
6
Applicant Total
140
Review Days
5
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEEDLE HOLDER, MICROVASCULAR
- K Number
- K771859
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- September 29, 1977
- Decision Date
- October 4, 1977
- Product Code
- FHQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHQ), ordered by most recent decision date.
WINGED NEEDLE HOLDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LAPAROSCOPIC NEEDLE HOLDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
25-100,25-220 VARIOUS NEEDLE HOLDERS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
25-230 TO 25-390 VARIOUS NEEDLE HOLDERS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Edward Weck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915378 | WECK TROCAR | Jun 29, 1992 | Substantially Equivalent |
| K914690 | LM15(TM), CATALOG NUMBER - 523821 | Mar 23, 1992 | Substantially Equivalent |
| K911915 | HEMOCLIP II | Jan 9, 1992 | Substantially Equivalent |
| K914470 | PNEUMO-SEAL(TM) | Nov 29, 1991 | Substantially Equivalent |
| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | Jul 2, 1991 | Substantially Equivalent |
| K902108 | HEM-O-LOK(TM) | Aug 6, 1990 | Substantially Equivalent |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | Aug 2, 1990 | Substantially Equivalent |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | Feb 15, 1990 | Substantially Equivalent |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Aug 27, 1987 | Substantially Equivalent |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | Jul 2, 1985 | Substantially Equivalent |