FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOOD, CLARION SURGEONS
K Number: K770261
·
Decision Mar 1, 1977
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
12
Applicant Total
62
Review Days
18
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
- HOOD, CLARION SURGEONS
- K Number
- K770261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- February 11, 1977
- Decision Date
- March 1, 1977
- Product Code
- FXY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FXY | Hood, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXY), ordered by most recent decision date.
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOOD, OPERATING, SURGICAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE BEARD COVER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERI-SHIELD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |