FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUNG RETRACTORS: DAVIDSON, SEMB
K Number: K930316
·
Decision Feb 10, 1994
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
33
Review Days
384
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
- LUNG RETRACTORS: DAVIDSON, SEMB
- K Number
- K930316
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thomasville Medical Assoc.
- Date Received
- January 22, 1993
- Decision Date
- February 10, 1994
- Product Code
- GAD
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAD), ordered by most recent decision date.
JRP Wound Spreader
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OTELO LL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DASH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUADRANT RETRACTOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Thomasville Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Feb 28, 1994 | Substantially Equivalent |
| K926531 | HYSTERECTOMY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926527 | ROTO FIT BIOPSY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926535 | GOMCO CIRCUMCISION CLAMP | Feb 25, 1994 | Substantially Equivalent |
| K926533 | Z-CLAMP FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926532 | ENDO CERVICAL CURETTE | Feb 25, 1994 | Substantially Equivalent |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Feb 25, 1994 | Substantially Equivalent |
| K930030 | SUCTION TUBES: HOUSE, BARON | Feb 25, 1994 | Substantially Equivalent |
| K926484 | CORSON MYOMA GRASPING FORCEPS | Feb 25, 1994 | Substantially Equivalent |