FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEM-O-LOK(TM)
K Number: K902108
·
Decision Aug 6, 1990
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
140
Review Days
90
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
- HEM-O-LOK(TM)
- K Number
- K902108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- May 8, 1990
- Decision Date
- August 6, 1990
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZP), ordered by most recent decision date.
InnoClip Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
InnoClip Disposable Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Polymer Ligation Clips
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hem-o-lok PurplePlus Large Polymer Ligating Clips
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GEM ZIPCLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLID CLIP Single Use Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| 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 |
| K851258 | WECK LX TM SKIN STAPLER | Jun 7, 1985 | Substantially Equivalent |