FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LASER SPECULA
K Number: K891044
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
10
Applicant Total
76
Review Days
17
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Basic Information
- Device Name
- LASER SPECULA
- K Number
- K891044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- February 28, 1989
- Decision Date
- March 17, 1989
- Product Code
- HDF
- 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 |
|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDF), ordered by most recent decision date.
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
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WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
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Other Clearances by Zinnanti Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925501 | NYLON COATED SPECULA | Jun 13, 1997 | Substantially Equivalent |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Jan 25, 1995 | Substantially Equivalent |
| K941457 | UTERINE INJECTOR WITH SPRING | Jan 24, 1995 | Substantially Equivalent |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Apr 7, 1994 | Substantially Equivalent |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Mar 24, 1994 | Substantially Equivalent |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Nov 12, 1993 | Substantially Equivalent |