FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K Number: K020726
·
Decision May 15, 2002
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
11
Review Days
70
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
- DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
- K Number
- K020726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dukal Corp.
- Date Received
- March 6, 2002
- Decision Date
- May 15, 2002
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIB), ordered by most recent decision date.
JFord Speculum Sleeve
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BRELLA-SPEC(TM) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IOB DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEARSPEC SINGLE USE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECULUM, VAGINAL, NONMETAL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOLPLUX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Dukal Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Mar 6, 2009 | Substantially Equivalent |
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | Mar 26, 2007 | Substantially Equivalent |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | Sep 15, 2006 | Substantially Equivalent |
| K984564 | ETHYL CHLORIDE DISPENSER | Dec 2, 1999 | Substantially Equivalent |
| K970457 | DUKAL ABD COMBINE PAD | May 8, 1997 | Substantially Equivalent |
| K970455 | DUKAL NON ADHERENT DRESSING | May 8, 1997 | Substantially Equivalent |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | Jan 18, 1996 | Substantially Equivalent for Some Indications |
| K940440 | DUKAL NON-WOVEN GAUZE | Mar 9, 1994 | Substantially Equivalent |
| K936095 | GAUZE SPONGE | Feb 2, 1994 | Substantially Equivalent |
| K931005 | DUKAL SKIN CLOSURE STRIP | Jul 14, 1993 | Substantially Equivalent |