FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOT TEMP CAUTERY
K Number: K771189
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
23
Applicant Total
140
Review Days
10
Basic Information
- Device Name
- HOT TEMP CAUTERY
- K Number
- K771189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- EDWARD WECK, INC.
- Date Received
- July 1, 1977
- Decision Date
- July 11, 1977
- Product Code
- HQP
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQP | Unit, Cautery, Thermal, Battery-Powered | FDA class 2 | Ophthalmic |
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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 |