FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MMODIFICATION TO LAMINARIA
K Number: K011512
·
Decision Jul 9, 2001
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
10
Applicant Total
23
Review Days
54
Basic Information
- Device Name
- MMODIFICATION TO LAMINARIA
- K Number
- K011512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A & A MEDICAL, INC.
- Date Received
- May 16, 2001
- Decision Date
- July 9, 2001
- Product Code
- HDY
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDY), ordered by most recent decision date.
ATAD ARD CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA TENT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA CUREX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by A & A MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K013437 | SF SH CATHETER, MODEL R65-945 | Nov 19, 2001 | Substantially Equivalent |
| K013491 | HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 | Nov 19, 2001 | Substantially Equivalent |
| K003949 | TACKER, MODEL R65-933 | Jul 25, 2001 | Substantially Equivalent |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 | May 16, 2001 | Substantially Equivalent |
| K010789 | CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 | Apr 27, 2001 | Substantially Equivalent |
| K010056 | UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 | Feb 1, 2001 | Substantially Equivalent |
| K000027 | INSUFFLATION NEEDLE, MODEL R65-933 | Apr 3, 2000 | Substantially Equivalent |
| K994256 | SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 | Feb 3, 2000 | Substantially Equivalent |
| K974038 | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT | May 11, 1998 | Substantially Equivalent |
| K974138 | ROCKET ELECTRODE | Jan 30, 1998 | Substantially Equivalent |